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gis catalog 2011 - Amg Infotek · SD2009 Stop Drill – Ø 2.0 mm-9.0 mm L SD2011 Stop Drill – Ø 2.0 mm-11.0 mm L SD2013 Stop Drill – Ø 2.0 mm-13.0 mm L STRAY Surgical Tray

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Page 1: gis catalog 2011 - Amg Infotek · SD2009 Stop Drill – Ø 2.0 mm-9.0 mm L SD2011 Stop Drill – Ø 2.0 mm-11.0 mm L SD2013 Stop Drill – Ø 2.0 mm-13.0 mm L STRAY Surgical Tray
Page 2: gis catalog 2011 - Amg Infotek · SD2009 Stop Drill – Ø 2.0 mm-9.0 mm L SD2011 Stop Drill – Ø 2.0 mm-11.0 mm L SD2013 Stop Drill – Ø 2.0 mm-13.0 mm L STRAY Surgical Tray

OsseoLink® Dental Implant System

3

T a b l e o f C o n t e n t s

Symbols and Abbreviations

General Information

• Symbols & Abbreviations ..................................... 3

• Warnings/Disclaimer/Copyrights/ Trademarks/Patents ........................................... 4

• Guarantee Program ............................................ 5

• Ordering/Terms of Sale ....................................... 6

• Fax Order Form .................................................. 7

• Instructions for Use ......................................... 8-9

System Overview .............................................. 10-11

Surgical Components & Procedures

• Implants/Packaging ..................................... 12-13

• Cover Screw .................................................... 14

• Healing Abutments ........................................... 15

• Surgical Kit/Maintenance .............................. 16-17

• Surgical Kit Components ............................... 18-25

– Drills/Countersinks ......................................18-19

– Taps/Implant Driver ................................... 20-21

– Hex Driver/Drill Extender/Parallel Pin ................. 22

– Depth Gauge/Implant Placement Guide ............. 23

– Torque Wrench .......................................... 24-25

• Surgical Procedures ..................................... 26-27

Prosthetic Components & Procedures

• Octacone Quad Connection ................................ 28

• Impression Copings .......................................... 29

• Laboratory Analog/Prosthetic Screw .................... 30

• Abutment Selection Guide ................................. 31

• Straight Abutments ...................................... 32-33

• Angled Abutments ............................................ 33

• Cast-to & castable abutments ............................ 34

• Ball abutments ................................................. 35

• Locator abutments ....................................... 36-37

• CAD/CAM Solutions .......................................... 37

Allografts ......................................................... 38-39

Sterile by gamma irradiation

Notsterile

Lot number/Batch number

Reference number/Article number/Catalog number/Item number

Use before expiration date

Single use only/Do not resterilize

Refer to instructions for use

Consult operating instructions

Keep away from sunlight

Keep dry

CE Marking

Manufacturer

United States Food and Drug Administration

Color Coding of Implant Diameters

Ø 3.5 mm implants Ø 4.0 mm implants Ø 5.0 mm implants

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5

Warning

The information presented is insufficient to allow for immediate use of the OsseoLink® Dental Implant System. Advanced training in the field of oral implantology along with in-depth knowledge of the system components are required prior to use.

Disclaimer of Liability

The use of this product is the responsibility of the end user. All liability for loss or damage attributable to the use of this product is excluded. The system is intended for use only with original OsseoLink components. Any use of third party components voids the warranty provided by OsseoLink and renders the product ineffective.

Availability

Some components of the OsseoLink Dental Implant System are not available in all markets.

Validity

Upon release, this publication supersedes all earlier versions.

Copyright/Trademarks

OsseoLink®, OsseoBond®, OctaCone™ Quad, Digital Abutment™, OsseoGuide™ and/or other products, marks, and logos are protected trademarks and the sole property of Global Implant Solutions, LLC and/or its affiliates. Any use of such marks is strictly prohibited and subject to prosecution under US and international law.

Patents

Several OsseoLink features may be protected by US and international patents.

Training

Dental implant therapy involves complex surgical and restorative procedures. Such procedures should be performed by dentists with proper training and education. Inadequate training can lead to surgical and prosthetic complications including implant and restoration failure.

1. Global Implant Solutions, LLC (GIS) guarantees that, if any of OsseoLink implants fail to integrate to the alveolar bone during the 5 year period after placement, GIS will replace the implant along with its restorative components present at the time of failure, with similar size OsseoLink components free of charge.

2. To be eligible for the OsseoLink guarantee, the following conditions must be met:

a. The provider must have used only original OsseoLink surgical and prosthetic components. b. The provider must have performed the surgical and restorative treatment in accordance with OsseoLink recommended treatment protocols at the time and in accordance with accepted dental implant practice parameters of care. c. The patient must have adhered to recommended maintenance protocols and good oral hygiene practices during the postsurgical and prosthetic phase. d. The provider’s account with OsseoLink or its designated distributors must be in good standing. 3. A completed Implant Failure Guarantee form needs to be completed by the provider claiming the implant failure. Failed implants and/or components need to be returned after proper sterilization has been performed.

4. This program does not cover implant failure due to traumatic injuries.

5. This guarantee is extended only to eligible treatment providers. Eligible providers include dentists and physicians with a current license at the time of treatment and claim. This guarantee is by no means extended to the benefit of the patient, laboratory technician, or any other party related to the patient’s episodes of care.

6. This guarantee is applicable in North America only. Other markets are subject to their local GIS-Distributor agreements.

7. The guarantee is subject to change without notice. Refer to Global Implant Solutions’ Implant Warranty Program for more details about terms and conditions of warranty.

1. The warranty on instruments is offered for a period of one (1) year from the date of purchase. This includes drivers, torque wrenches and other surgical instruments such as osteotomes.

2. The warranty on surgical drills is offered for a period of 90 days from the date of purchase. Surgical drills are subject to wear and should be checked periodically for sharpness and integrity. Drills exhibiting signs of dullness, wear or corrosion should be replaced as their use may compromise clinical outcome. It is generally recommended to replace drills after 15 – 20 osteotomies depending on the quality of bone.

OsseoL ink ® Denta l Imp lant Sys tem Guarantee Program

Warranty on Instruments, Surgical Drills and Torque Wrenches

4

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International Orders

Customers outside the US should contact their local OsseoLink distributor or dealer. Please contact OsseoLink directly for information about your specific territory.

US Orders

Orders can be placed online, by fax, or by phone. All orders placed before 4:00 PM (EST) will be processed the same day.

A preprinted fax order form is available in this catalog for use. The form can also be downloaded from our website www.osseolink.com. Fax orders can be sent to: 1–877–OSSEO–88 (1–877–677–3688) or (781) 232–9477.

Shipping Orders shipped within the continental US are shipped using second day courier service unless otherwise requested. Shipping fees are waived for orders of $2,000 or more. Shipping terms are generally F.O.B. origin, prepaid.

Items are packaged to ensure product integrity during shipping. If package integrity is violated during shipping, please contact OsseoLink immediately to arrange for a replacement.

Return Policy

To return implants and other components, please contact OsseoLink to obtain a Return Authorization Number (RAN). All returned items must be in their unopened and undamaged original packaging. Shipping charges for the return and exchange are the responsibility of the customer. The following terms apply:

• Items returned within 30 days from the date of purchase are eligible for full credit.

• Items returned between 31 – 90 days from the date of purchase are eligible for exchange only.

• No returns or exchanges are allowed after 90 days from the date of purchase.

• No returns or exchanges are allowed on previously exchanged items.

Billing

Payment must be made at the time of order. American Express, VISA, MasterCard, Discover, and automatic checking withdrawal payments are accepted.

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F a x O r d e r F o r m ( 8 7 7 ) 6 7 7 - 3 6 8 8 o r ( 7 8 1 ) 2 3 2 - 9 4 7 7O r d e r i n g - T e r m s o f S a l e

1 8 7 7 - O S S E O - 8 8 ( U S t o l l f r e e ) w w w . o s s e o l i n k . c o m

REF No. Item Description

IMP3590 Implant 3.5 mm x 9.0 mm with Cover Screw

IMP3511 Implant 3.5 mm x 11.0 mm with Cover Screw

IMP3513 Implant 3.5 mm x 13.0 mm with Cover Screw

IMP4075 Implant 4.0 mm x 7.5 mm with Cover Screw

IMP4090 Implant 4.0 mm x 9.0 mm with Cover Screw

IMP4011 Implant 4.0 mm x 11.0 mm with Cover Screw

IMP4013 Implant 4.0 mm x 13.0 mm with Cover Screw

IMP5075 Implant 5.0 mm x 7.5 mm with Cover Screw

IMP5090 Implant 5.0 mm x 9.0 mm with Cover Screw

IMP5011 Implant 5.0 mm x 11.0 mm with Cover Screw

IMP5013 Implant 5.0 mm x 13.0 mm with Cover Screw

UNICS Cover screw (separate packaging)

UNILA Universal Lab Analog

UNIPS Universal Prosthetic Screw

UICL Impression Coping-Long

UICS Impression Coping-Short

ICSCL Impression Coping Screw-Long

ICSCS Impression Coping Screw-Short

BA20 Ball Abutment 2.0 mm (H)

BA40 Ball Abutment 4.0 mm (H)

CAPORI Ball Abutment Cap & 4 O-rings

O-rings – Set of 6ORING

01911 1.0 mm LOCATOR® Abutment

01912 2.0 mm LOCATOR® Abutment

01913 3.0 mm LOCATOR® Abutment

01914 4.0 mm LOCATOR® Abutment

01915 5.0 mm LOCATOR® Abutment

8519-2 LOCATOR® Male Processing Package (2 Pack)

8540-2 LOCATOR® Extended Range Male Processing Package (2 Pack)

8393 LOCATOR® Core Tool

8505 LOCATOR® Impression Coping (4 Pack)8530 LOCATOR® Female Analog (4 Pack)

UCLAGE Abutment – Cast-to Engaging

UCLAGNE Abutment – Cast-to Non-engaging

UCLAPNE Abutment – Castable-Non-engaging

TI40 Abutment Anatomic – Titanium Ø 4.5 mm

TI50 Abutment Anatomic – Titanium Ø 5.5 mm

TI50N Abutment Non Anatomic – Titanium Ø 5.5 mm

TI60N Abutment Non Anatomic – Titanium Ø 6.0 mm

ATI40 Abutment – Titanium – Angled Ø 4.5 mm

ATI50 Abutment – Titanium – Angled Ø 5.5 mm

TI40N Abutment Non Anatomic – Titanium Ø 4.5 mm

TI50N0 Abutment Non Anatomic – Titanium Ø 5.5 mm, 0.5 mm (H)

TI40N0 Abutment Non Anatomic – Titanium Ø 4.5 mm, 0.5 mm (H)

TI50N4 Abutment Non Anatomic – Titanium Ø 5.5 mm, 4.0 mm (H)

TI40N4 Abutment Non Anatomic – Titanium Ø 4.5 mm, 4.0 mm (H)

Quantity REF No. Item Description

RB6 Round Bur

PD 15 Lindemann Surgical Bur

TD20S/TD20L Drill – Ø 2.0 mm Short/Long

TD25S/TD25L Drill – Ø 2.5 mm Short/Long

TD33S/TD32L Drill – Ø 3.3 mm Short/Long

TD39S/TD39L Drill – Ø 3.9 mm Short/Long

TD43S/TD43L Drill – Ø 4.3 mm Short/Long

TD49S/TD49L Drill – Ø 4.9 mm Short/Long

CSINK35 Countersink Drill Ø 3.5 mm

CSINK40 Countersink Drill Ø 4.0 mm

CSINK50 Countersink Drill Ø 5.0 mm

TAP35 Tap Drill – Ø 3.5 mm

TAP40 Tap Drill – Ø 4.0 mm

TAP50 Tap Drill – Ø 5.0 mm

SD2009 Stop Drill – Ø 2.0 mm-9.0 mm L

SD2011 Stop Drill – Ø 2.0 mm-11.0 mm L

SD2013 Stop Drill – Ø 2.0 mm-13.0 mm L

STRAY Surgical Tray with Instrument Set

TRAY Surgical Tray (no instruments)

HDH050 Hex Driver 0.05" (1.25 mm)

DADAP Driver Adapter

ITWISO Variable Torque Wrench-Latch Connection

IDRA Ratchet/Torque Wrench with Adapter

UID Universal Implant Driver

DEXT Drill Extension

DEPG Double Ended Depth Gauge

IPG Implant Placement Guide

PPIN Parallel Pin

SC0465AI 1.0 cc Cortical Cancellous Chips 0.5-1.0 mm

SC0466AI 2.0 cc Cortical Cancellous Chips 0.5-1.0 mm

SC0467AI 5.0 cc Cortical Cancellous Chips 0.5-1.0 mm

Quantity

HA4030 Healing Abutment Ø 4.0 mm, 3.0 mm (H)

HA4050 Healing Abutment Ø 4.0 mm, 5.0 mm (H)

HA5030 Healing Abutment Ø 5.0 mm, 3.0 mm (H)

HA5050 Healing Abutment Ø 5.0 mm, 5.0 mm (H)

HA6030 Healing Abutment Ø 6.0 mm, 3.0 mm (H)

HA6050 Healing Abutment Ø 6.0 mm, 5.0 mm (H)

Implants & Cover Screws

Restorative Components

Surgical Drills/Instruments

Allografts

Healing Abutments

02773

02774

02775

02776

02777

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Indications for Use OsseoLink Dental Implants are intended for use in partially or completely edentulous maxillary or mandibular arches for the support and/or retention of single, multiple-unit, or full arch fixed and/or removable dental restorations. The implants can be surgically placed via either a one-stage or two-stage approach.

Special Indications for Ø 3.5 mm Implants:

Smaller diameter implants are only used in cases with reduced mechanical demands. The implants are intended for:• Mandibular central and lateral incisors and maxillary

lateral incisors. • Multiple tooth replacement with aid of other implants.• Stabilization of dentures.

The placement of individual Ø 3.5 mm diameter implants in the molar region is not recommended.

Contraindications

Contraindications include but are not limited to poor general health status, serious internal medical problems, uncontrolled diabetes, vascular disorders, uncontrolled bleeding disorders, anticoagulant therapy, inadequate wound healing, connective tissue disorders, chemo and radiation therapy, metabolic bone disease, uncontrolled endocrine disease, psychiatric disorders, drug and alcohol abuse, and allergies to titanium alloys.

Local Contraindications

Local contraindications include but are not limited to inadequate bone volume in terms of width and height, oral infection, periodontal disease, parafunctional habits, severe xerostomia, poor oral hygiene, non compliance, and inability to maintain proper oral hygiene.

Material

Implants are made of titanium alloy (Ti6Al4V) material. OsseoBond surface microstructure is achieved by blasting the Ti surface with a biocompatible resorbable medium to achieve optimal Ra values for osseointegration.

Packaging and Sterility

OsseoLink implants are packaged sterile in a vial along with a cover screw. Gamma radiation is used for sterilization of the implants. The intact sealed packaging protects the implant from the outside environment. With proper storage, sterility is ensured up to the expiration date on the label. Implants with damaged sterile packaging should not be used. Contaminated implants should not be re-sterilized. Re-use of implants can result in clinical failure and complications including, but not limited to, infection, failure of implants to integrate, bone loss, and damage to adjacent structures. The OsseoLink implant driver is used to carry the implant from the vial to the prepared surgical site. Care must be taken not to handle the blasted surface of the implant since this may alter its characteristics. All other instruments should be sterilized by autoclave according to standard sterilization procedures. (Gravity, Minimum 121°C for 30 minutes. Dry time of 15 minutes).

Shelf Life

Expiration date is clearly noted on the package of each implant.

Treatment Planning

Comprehensive patient evaluation, pre-operative radiographs, pre-operative diagnosis and treatment planning should be completed prior to implant therapy. Inadequate planning and evaluation can lead to implant complications including implant failure.

Post-Operative Care

It is important that the patient be followed up closely following surgery. The use of proper oral rinse and maintenance of good oral hygiene is advised.

Surgical Site Preparation

Implant site osteotomies should be prepared with the drills provided in the Osseolink surgical tray. The recommended drilling speed is between 500 rpm and 1200 rpm. Drilling is accomplished under copious irrigation. Care should be taken to avoid overheating of bone. The use of dull drills should be avoided as it induces undue trauma to the bone. It is generally recommended to replace drills after 15 – 20 osteotomy preparations depending on the quality of bone.

I n s t r u c t i o n s F o r U s e

Ø 3.5 mm Ø 4.0 mm Ø 5.0 mm Implants Implants Implants

PD15 x x xTD20S/TD20L x x xTD25S/TD25L x x xTD33S/TD33L x x xTD39S/TD39L x xTD43S/TD43L xTD49S/TD49L x

Surgical Placement of Implants

Verify implant diameter and length from the product’s label. Attach label to patient’s record. Open the outer packaging and remove the inner blister pack. Peel off cover of blister pack and introduce sterile inner vial to surgical field. Open implant vial by removing the vial lid with the OsseoLink logo.

The implant and cover screw are contained in the lower part of the vial suspended in small chambers. Use the OsseoLink implant driver to carry the implant to the prepared surgical site. The implant carrier is designed to break at a predetermined torque value in order not to damage the implant. If the implant driver breaks, remove the implant and assure proper implant bed preparation.

The implant can be inserted with either a ratchet or dental hand-piece using the OsseoLink implant driver. The implant should be introduced to the osteotomy using high torque and low speed not exceeding 20 rpm.

For two-stage approach, install cover screw using the 1.25 mm hex driver. For one-stage approach, install a healing abutment of appropriate length and diameter using the 1.25 mm hex driver. Cover screws and healing abutments should be torqued manually.

Healing Phase of OsseoLink Implants

Generally, implants should be allowed to heal for a period of two to four months prior to being restored depending on bone quality, type, and the patient's general medical conditions. Immediate and early loading can be done with proper case selection and according to approved immediate loading protocols as described in the literature. If immediate loading is to be contemplated, the implant should have an initial stability torque value of no less than 35 Ncm, the occlusal environment be well controlled, multiple adjacent implants be splinted, and in the case of complete edentulism, a minimum of four implants be connected in the mandible and six implants be connected in the maxilla.

O s s e o L i n k C o v e r S c r e w a n d H e a l i n g A b u t m e n t s

OsseoLink Cover Screws

Indications

Cover screws are used when submerged healing is desired in two stage implant surgery procedures. Healing abutments are used at the time of implant placement when non submerged (single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

Contraindications

Contraindications for dental implant treatment as stated above.

Material

Titanium alloy

Installation

Cover screws and healing abutments are installed using the 1.25 mm hex driver with hand torque.

Packaging and Sterility

Cover screws are packaged with the implant in a sterile vial. Sterility in ensured up to the expiration date on the package unless the seal has been damaged.

Healing abutments are packaged non sterile in sealed pouches and must be sterilized by autoclave method prior to use (Gravity, Minimum 121°C for 30 minutes. Dry time of 15 minutes).

OsseoLink Abutments

Sterilization and Packaging

OsseoLink abutments are packaged non sterile in sealed pouches. Sterilization is required for all abutments and impression copings before use on patients. Autoclave all components according to recommended protocols. (Gravity, Minimum 121°C for 30 minutes. Dry time of 15 minutes)

Indications

OsseoLink abutments are connected to OsseoLink implants via prosthetic screws for the support and/or retention of dental restorations.

Contraindications

Contraindications for dental implant treatment as stated above.

Material

Titannium alloy, YTZP Zirconia

Installation

OsseoLink abutments are installed on the corresponding implants via the prosthetic screw using the 1.25 mm hex driver. Thirty five (35) Ncm of torque is recommended to achieve optimal fit between the components. OsseoLink ball abutments are solid one-piece abutments that are secured by accessing the hex portion of the ball top using the 1.25 mm hex driver. Twenty five (25) Ncm of torque is recommended to ensure secure installation of ball abutments.

Non-axial Loading

Non-axial loading of abutments in excess of 30° from the long axis of the implant should be avoided.

D r i l l s

The following drilling sequence is recommended:

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OsseoLink System

Global Implant Solutions OsseoLink Dental Implant System was born out of a collaborative effort in research design, innovation, and clinical experience of highly qualified specialists in the field of modern dental implantology. With the clinician as the main focus, this system provides a high quality advanced system that is very simple to use yet highly versatile. The OsseoLink system features the latest concepts in implant design and technology that have been scientifically proven to increase treatment predictability and success.

Implants are manufactured in our FDA registered ISO-13485 certified manufacturing facilities in the United States according to the highest standards of quality manufacturing.

Our Excellence, Simplicity, Versatility motto is truly manifested in every aspect of this system.

E x c e l l e n c e S i m p l i c i t y

V e r s a t i l i t y

Prosthetic

Simplicity provided through the innovative OctaCone Quad connection. The self guiding feature of this connection leads to the ability to confirm component seating tactically without the need for radiographic verification.

Surgical

• Self tapping reverse buttress thread design.

• Tapered apical end with cutting grooves for reduced surgical trauma.

• Ease of placement with maximum initial stability.

• Laser marking on surgical drills for improved visibility.

• Reduced number of drills needed for surgical procedure.

• Precision designed drills for use in all types of bone.

• Reduced instrumentation for simplicity.

• Mountless design for simplified surgery.

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Tapered end

• Allows easier placement of the implant at the time of surgery with maximum initial stability and fi t.

Cutting features

• At the implant terminus facilitate self tapping and maximize bone cutting efficiency with minimal trauma to the bone.

OsseoBond® Surface Technology

• Surface treatment provides a rough implant surface for increased bone-implant contact (BIC).

• Even roughness without residue or debris on the implant surface ensures optimal clinical outcome.

Dual external thread geometry

• Microgrooves in the cervical region of the implant reduce stress and provide optimal crestal bone response.

• The reverse buttress macro threads provide maximum initial implant stability and increased surface area for improved bone to implant contact.

Beveled neck with “Platform Switch”

• Medialization of the Implant-Abutment Junction (IAJ).

• Prevents tissue creep from interfering with component seating.

OctaCone™ QUAD Connection

• Internal connection with four distinct indexing positions for maximum stability and reduced stress to the prosthetic screw.

• Conical fit with superior seal at the implant-abutment junction.

• 13° taper for easy abutment placement and prosthetic flexibility.

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OsseoLink offers innovative, simple, and versatile solutions to a wide range of prosthetic scenarios. From the simple posterior restoration to the most esthetically demanding challenges, excellent results are consistently achieved.

ZirconiumAbutments

UCLAAbutments

AngledAbutments

TitaniumAbutments

OverdentureAbutments

LocatorAbutments

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5 ZircrconiumoniumUCUCLLAAAngledTitaniuaniumm OverrdedenntutureLoLocator DigitalAbutment™

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OsseoLink implants are packaged sterile with a cover screw and are made of titanium alloy Ti6Al4V with OsseoBond® surface treatment. Our implant packaging consists of an outer cardboard box that contains a blister pack. The blister pack is sealed with a lid and houses a sterile vial that includes the implant and the cover screw. This innovative design allows for easy introduction of the sterile

I m p l a n t s

vial into the surgical f ield with ease and simplicity. Once the vial cover is removed, the surgeon will gain immediate access to the implant and cover screw without the need for any disassembly of components. The implant packaging has appropriate label ing for identification of the implants. Additional peel-and-stick labe ls are prov ided for inclusion into the patient’s medical record.

REF No. LOT No. Diameter Color Code

Bar CodeExpiration Date(Year/Month)

IMPXXXX

XXXXXXJJJJ-MM

Implant & Cover ScrewO 4.0 mm X 11.0 mm

REF

Implant Diameterand Length

REF

Ø 5.0 mm x 7.5 mm IMP5075*

Ø 5.0 mm x 9.0 mm IMP5090

Ø 5.0 mm x 11.0 mm IMP5011

Ø 5.0 mm x 13.0 mm IMP5013

REF

Ø 3.5 mm x 9.0 mm IMP3590

Ø 3.5 mm x 11.0 mm IMP3511

Ø 3.5 mm x 13.0 mm IMP3513

Ø 3 . 5 m m I m p l a n t s

Ø 4 . 0 m m I m p l a n t s

Ø 5 . 0 m m I m p l a n t s

REF

ØØØØ 5.0 mm x 7.5 mm IMP5075*

ØØ 5.0 mm x 9.0 mm IMP5090

ØØ 5.0 mm x 11.0 mm IMP5011

Ø 5.0 mm x 13.0 mm IMP5013

REF

Ø 3.5 mm x 9.0 mm IMP3590

Ø 3.5 mm x 11.0 mm IMP3511

Ø 3.5 mm x 13.0 mm IMP3513

Ø 3 . 5 m m I m p l a n t s

Ø 4 . 0 m m I m p l a n t s

Ø 5 . 0 m m I m p l a n t s

REF

Ø 4.0 mm x 7.5 mm IMP4075*

Ø 4.0 mm x 9.0 mm IMP4090

Ø 4.0 mm x 11.0 mm IMP4011

Ø 4.0 mm x 13.0 mm IMP4013

length

body diameter

length

body diameter

length

body diameter

apical diameter

apical diameter

apical diameter

*Available in EU markets. USA FDA clearance pending.

Ø 3.5 mm implants Ø 4.0 mm implants Ø 5.0 mm implants

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Cover Sc rew H e a l i n g A b u t m e n t s

14

A cover screw is provided for use with submerged implant placement technique (2-stage technique). The cover screw is used to close and protect the implant’s internal connection during the submerged healing phase. The universal cover screw is compatible with all three available implant diameters of the OsseoLink system.

Each cover screw has a hexagonal socket that allows for frictional fit with the 0.05" (1.25 mm) hex driver. Gentle manual torque should be used when installing the cover screws. Recommended torque value is 5–10 Ncm.

Cover screws are packaged sterile with each implant in the same vial. The sterile vial allows direct access to the cover screw for safe transfer into the oral cavity with the aid of the 0.05" (1.25 mm) hex driver. Moreover, the cover screw can be ordered individually packaged non sterile in a sealed pouch.

Material composition: Titanium Alloy Ti6Al4V.

REF: UNICS(when ordered separately)

OsseoLink healing abutments are solid units that are designed to ensure predictable healing and emergence profile of the soft tissue for maximum esthetics. They can be used during soft t issue healing following second stage surgery or as the transgingival portion if a non-submerged implant placement technique was chosen.

Two different collar heights and three different diameters provide a combinat ion o f s i x d i f f e rent s i zes fo r max imum f lex ib i l i t y. Laser e tched mark ing prov ides clear labeling of diameter (Ø) and transgingival height (H).

Each healing abutment has a hexagonal socket that allows for frictional fit with the 0.05" (1.25 mm) hex driver. Installation is with gentle manual torque using the hex driver. Recommended torque value is not to exceed 10 Ncm.

All healing abutments are made of titanium alloy (Ti6Al4V).

Healing abutments are provided non sterile in sealed pouches and must be sterilized by autoclave method prior to use. The following sterilization cycle is recommended:

Steam Gravity Cycle: Minimum of 121̊ C / 250˚F for 30 minutes with minimum dry time of 15 minutes.

Ø 3.5 mm Ø 4.0 mm Ø 5.0 mm

Single Cover Screw For All Implant Diameters

Ø 6 . 0 m m H e a l i n g A b u t m e n t s

REF

Ø 6.0 mm x 3.0 mm HA6030

Ø 6.0 mm x 5.0 mm HA6050

Ø 5 . 0 m m H e a l i n g A b u t m e n t s

REF

Ø 5.0 mm x 3.0 mm HA5030

Ø 5.0 mm x 5.0 mm HA5050

Ø 4.00 mm

Ø 5.00 mm

Ø 6.00 mm

Ø 4 . 0 m m H e a l i n g A b u t m e n t s

REF

Ø 4.0 mm x 3.0 mm HA4030

Ø 4.0 mm x 5.0 mm HA4050

height

height

height

Ø 3.53 5 mmmm Ø 4.04 0 mm mm Ø Ø 5 05.0 mm mm

ingle Cover Screw For All Implant Diameters

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Surgical Kit

The surgical kit consists of three main parts. A clear lid for maximum visibility, a middle shelf with grommets that hold the surgical drills and drivers, and a bottom shelf that holds the torque wrench and other instruments. The middle shelf is removable and can fit inside the lid. This provides the surgeon with ready access to all the needed components at once. A compact and efficient design allows for optimal space utilization of the sterile field and ensures that the kit can fit into most in-office autoclaves.

The layout of the surgical kit is designed for simplicity. The drilling sequence follows a straight line from left to right in the middle section of the tray. Color coded zones, silicon grommets and clear labeling further aid in drill selection and identification.

The red zone contains the drills needed for the placement of Ø 3.5 mm implants.

The yellow zone contains an additional drill for the placement of Ø 4.0 mm implants.

The green zone has two additional drills that are needed for the placement of Ø 5.0 mm implants.

Two rows of gray grommets on the far right side contain additional accessories including implant drivers, hex drivers, a drill extender, and parallel pins.

Four additional grommets are reserved for additional parts as deemed necessary by each clinician's preference.

Surgical Kit Maintenance

The surgical kit is supplied non-sterile and must be cleaned and sterilized before each use.

1. Wash tray with appropriate detergent, rinse thoroughly and dry.

2. Use a soft brush with detergent to remove any bone and soft tissue remnants and rinse thoroughly. Clean surgical kit instruments in ultrasonic bath with appropriate solution for 10 minutes. Rinse thoroughly and dry.

3. Position instruments in the tray following the labeling indicated on the tray.

4. Wrap tray with appropriate sterilization wrap prior to autoclaving.

5. We recommend the following guidelines for sterilization:

a. Steam Prevacuum Cycle: 132° C/270° F for 4 minutes with minimum dry time of 20 minutes.

b. Steam Gravity Cycle: 121° C/250° F for 60 minutes with minimum dry time of 15 minutes.

Caution

• Do not place tray on its side or upside down into autoclave chamber.

• Do not use heat sterilization or chemiclave.

• Avoid use of oxidizing agents such as peroxide when cleaning instruments to prevent corrosion.

• Do not place corroded, rusty instruments into autoclave chamber.

• Monitor sterilization equipment regularly to ensure proper function.

O s s e o L i n k S u r g i c a l K i t

Removable middle shelf can fit inside the lid for optimal space utilization.

RB6 TD20L TD25L TD33L TD39L TD43L TD49L

PD15 TD20S TD25S TD33S TD39S TD43S TD49S HDH050DEXT

DADAP PPIN

UIDCSINK35 CSINK40 CSINK50

TAP35 TAP40 TAP50

Surgical Kits REF

Surgical tray with instrument set STRAY Surgical tray (no instruments) TRAY

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Drills

The surgical drills are made of high quality stainless steel material and are all externally irrigated. The recommended drilling speed is 450 – 800 rpm. Slower drilling speeds are recommended with softer bone and larger drill diameters.

Laser etched markings on the drill shank provide clear labeling of the drill’s reference number and diameter (Ø). Drills are compatible with standard latch-type dental handpieces.

Depth marks are standardized on all drills regardless of drill length or diameter. The marks are as follows:

• 7.5 mm line

• 9.0 mm – 11.0 mm band

• 13.0 mm – 15.0 mm band

The drills have a slight taper at their tip that corresponds to the apical diameter of implant body. This allows for

simplified sequential oseteotomies and improved preparation of the implant recipient site.

S u r g i c a l K i t C o m p o n e n t s

7.5mm

9.0mm

11.0mm

13.0mm

REF NO.

DRILLDIAMETER

15.0mm

Countersink Drills/Crestal Bone Drills

Countersink drills are made for use in cases where dense bone is encountered to ensure passive fit of the implant neck into the surgical site. These drills are designed to enlarge the crestal area of the implant site in the area of dense cortical bone. The drills are used following the use of the final drill size for each implant. Three drill sizes are provided that correspond to the three OsseoLink implant diameters (Ø 3.5 mm, Ø 4.0 mm, Ø 5.0 mm).

The dri l ls feature a non-cutting cylindrical area that helps guide the drill alignment and acts as a pilot. A distinct groove separates the cutting and non-cutting areas of the drills for surgical clarity. The cutting area matches the shape of the implant neck. All drills feature titanium

nitride (TiNi) coating to optimize the surface hardness, increase lubricity, and extend drill longevity.

Countersink drills are considered site specific drills and should be used based on clinical judgment of bone density at the time of surgery. Care should be taken not to over prepare the site as this can cause loss of initial implant stability. Slower drilling speeds (<500 rpm) are generally recommend when countersink drills are used.

CSINK35 – Ø 3.5 mm countersink drill. Used for Ø 3.5 mm OsseoLink implants in dense bone

CSINK40 – Ø 4.0 mm countersink drill. Used for Ø 4.0 mm OsseoLink implants in dense bone

CSINK50 – Ø 5.0 mm countersink drill. Used for Ø 5.0 mm OsseoLink implants in dense bone

Surgical Drills REF

Round Cortical Perforation Drill RB6 Ø 1.5 mm Lindemann Bur PD15

Ø 2.0 mm Short Drill TD20S

Ø 2.0 mm Long Drill TD20L

Ø 2.5 mm Short Drill TD25S

Ø 2.5 mm Long Drill TD25L

Ø 3.3 mm Short Drill TD33S

Ø 3.3 mm Long Drill TD33L

Ø 3.9 mm Short Drill TD39S

Ø 3.9 mm Long Drill TD39L

Ø 4.3 mm Short Drill TD43S

Ø 4.3 mm Long Drill TD43L

Ø 4.9 mm Short Drill TD49S

Ø 4.9 mm Long Drill TD49L

Countersink Drills REF Ø 3.5 mm Countersink Drill CSINK35

Ø 4.0 mm Countersink Drill CSINK40 Ø 5.0 mm Countersink Drill CSINK50

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S u r g i c a l K i t C o m p o n e n t s

Bone Taps*

OsseoLink implants are considered self- tapping implants. However, in some clinical situations, practitioners may prefer to tap dense cortical bone to ensure full and passive seating of the implant into its prepared osteotomy. The bone taps are used to prepare the implant thread profile into the implant recipient bed thus ensuring pressure free seating. If tapping the site is elected, it should be performed as the last step prior to implant placement at a very low speed (<50 rpm). Three bone taps are provided that correspond to the three OsseoLink implant diameters (Ø 3.5 mm, Ø 4.0 mm, Ø 5.0 mm).

Laser markings on the tap shanks provide clear indication of depth and are identical to the depth marks of the OsseoLink implant drills (7.5 mm, 9.0 mm, 11.0 mm, 13.0 mm, 15.0 mm).

The cutting area of the bone taps are coated with titanium nitride (TiNi)

for increased surface hardness, enhanced lubricity, and improved drill longevity.

Bone taps are considered site specific drills and should be used based on clinical judgment of bone density at the time of surgery. Care should be taken not to overprepare the site as this can cause loss of initial implant stability.

Bone taps should be used at extremely slow speeds in a clockwise direction (<50 rpm). Care should be taken not to overheat the bone during the tapping procedure. The bone taps are removed from the site through counter-clockwise rotation using similar speed.

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TAP40 – Ø 4.0 mm Bone Tap. ������������������ ����������������������������� ���������������� ���������������

TAP50 – Ø 5.0 mm Bone Tap. ������������������ ����������������������������� ���������������� ���������������

Implant Driver (REF UID)

OsseoLink implants are designed for surgical placement without the need to use implant mounts. This simplified mountless surgical delivery provides easier access in cases with limited interarch distance, and eliminates the tedious process of disassembling the implant mount after implant installation.

The OsseoLink implant driver is designed to carry the implant into the prepared osteotomy site. Friction precision fit between the driver and the internal connection of the implant allows for safe and efficient transfer of the implant from its vial to the surgical field. The driver can be used with either a latch-type dental handpiece, the OsseoLink Torque Wrench (REF ITWISO), or the Driver Adapter (REF DADAP). The Implant Driver is compatible with all three implant diameters with the OctaCone Quad connection.

Vertical laser etched markings on the driver correspond with the four indexing posi- tions of the OctaCone Quad connection.

This allows the surgeon to position the implants so that one of the OctaCone Quad connection protrusions is on the buccal side. This positioning, while not critical, provides for optimal use of prefabricated prosthetic components such as the titanium straight and angled abutments. The driver has a horizontal laser etched mark that corresponds to 3.0 mm from the implant neck. This provides the surgeon with a visual indicator of implant depth in cases of flapless surgery or immediate implant placement.

The driver is designed to fail at a specified torque that is below the implant rupture torque. This innovative feature minimizes the risk of implant fracture during installation with its associated patient morbidities. The surgeon can place the implant using this driver with peace of mind that safe torque limits to the implant will not be exceeded. The hexagonal shank is designed to facilitate retrieval of the driver and the implant should the driver fail during implant installation.

3.0 mm

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Bone Taps REF Ø 3.5 mm Bone-tapping Drill TAP35

Ø 4.0 mm Bone-tapping Drill TAP40 Ø 5.0 mm Bone-tapping Drill TAP50

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Hex Driver (REF HDH050)

The 0.05" (1.25 mm) hex driver can be used for installation and removal of cover screws, healing abutments, prosthetic screws, and ball abutments. It is the only driver required for all prosthetic procedures. The driver can be used with either the driver adapter (REF DADAP), the torque wrench (REF ITWISO), or a latch type dental handpiece. The hex driver is designed to provide friction fit with OsseoLink components for safe transfer of the components to the oral cavity.

Drill Extender (REF DEXT)

A drill extension is provided to add length to all components with a latch-type attachment. The drill extension can be used in cases where additional length is desired. The extension adds 16 mm to the working length of each component it is attached to.

Parallel Pin (REF PPIN)

Parallel pins are provided in the surgical kit to aid the surgeon in the alignment of implants during surgical placement.

The pins are double sided with different diameters on each side. The first side is 2.0 mm in diameter and can be used following the Ø 2.0 mm drill early in the osteotomy development process. The other side is 2.5 mm in diameter and can be used following the Ø 2.5 mm drilling step for verification purposes.

Laser etched marks and grooves indicate depths of 7.0 mm and 9.0 mm. This permits visual and radiographic identification of osteotomy depth. The total length of each end is 10.0 mm. The middle section of the pin is 5.0 mm in diameter and 2.0 mm in height.

S u r g i c a l K i t C o m p o n e n t s

Hex Driver

Drill Extender

Parallel Pin Implant Placement GuideImplant Placement Guide

er

Drill Extender

and grooves indicate depths of 7.0 mm and 9.0 mm. phic identification of osteotomy depth. The total length ofe section of the pin is 5.0 mm in diameter and 2.0 mm in

Parallel Pin

2.0 mm5.0 mm 2.5 mm

10.0 mm

9.0 mm

7.0 mm

13.0 mm

3.8 mm

Depth Gauge

11.0 mm

9.0 mm

7.0mm

2.0 mm

13.0 mm

11.0 mm

9.0 mm

7.0mm

Depth Gauge (REF DEPG)

A double-ended depth gauge is provided in the surgical kit. It is located in the lower tray compartment. The gauge has blunted tapered ends for ease of placement and verification of osteotomy depth and wall integrity. One end is 2.0 mm in diameter while the other end is 3.8 mm in diameter. Laser etched markings and grooves indicate depths of 7.0 mm, 9.0 mm, 11.0 mm, and 13.0 mm.

Implant Placement Guide (REF IPG)

The implant placement guide can be used during the presurgical planning or during the surgical procedure as an aid to measure available space for implant placement.

Four distinct ends with different widths give the clinician precise measurement control. The gauge ends have the following dimensions:

• 2.0 mm, 4.0 mm, 6.0 mm, and 8.0 mm (even numbers).

• 3.0 mm, 5.0 mm, 7.0 mm, 9.0 mm, and 11.0 mm (odd numbers).

• Implant-Implant distance guide from center to center for each diameter of OsseoLink implants. Use of the guide will allow 3.0 mm of inter-implant bone.

• Implant-Tooth distance guide for each diameter of OsseoLink implants. Use of the guide will leave 1.75 mm of bone adjacent to a natural tooth. The opposite side of this part has millimeter marks that can be used to measure needed dimensions.

Holes in the middle of the odd and even ends provide added measurement capabilities. The holes are compatible with the 1.5 mm Point Drill (REF PD15).

The guide is merely an aid to facilitate measurements and should not be used as a substitute to conventional surgical guides.

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T o r q u e W r e n c h ( R E F I T W I S O )

Variable Torque Functionality (15 Ncm, 25 Ncm, 35 Ncm)

The desired driver tip is attached to the torque wrench head.

The desired torque value is dialed in by turning the calibrator end of the torque wrench until the desired value is shown in the window.

For tightening, the torque wrench is turned in the direction of the arrow on the IN side.

For loosening, the torque wrench is turned in the direction of the arrow on the OUT side.

Once the desired torque value is reached, the torque wrench handle will snap away.

An adjustable torque wrench is provided with the OsseoLink surgical kit. This instrument can be used as a ratchet with unlimited torque or as a torque- controlled wrench with adjustable torque settings of 15 Ncm, 25 Ncm, and 35 Ncm. The torque wrench is compatible with standard ISO latch-type driver tips. During the surgical placement

of the implant, the implant driver (REF UID) can be used with the torque wrench to drive the implant into the prepared osteotomy. In the restorative phase, the 0.05" (1.25 mm) hex driver (REF HD050) can be used to drive the prosthetic screw and abutments to their desired torque values. A torque value of 30–35 Ncm is recommended for all prosthetic situations in the OsseoLink system.

1

2

3

4

W I S O )

p is attached ead.

nch is OsseoLink

trument can ratchet with

ue or as a torque- rench with adjustable

settings of 15 Ncm, 25 and 35 Ncm.

The torque wrench is compatible with standard ISO latch-type drivertips. During the surgical placement

o(REtorquinto ththe resto(1.25 mmHD050) can prosthetic screto their desired ttorque value of 3recommended for alsituations in the OsseoLin

5The calibrator is turned all the way back. The shaft is pulled away from the head and turned 90° and then tightened.

The torque wrench can then be used as a ratchet with no torque control values. Follow the IN and OUT arrows for tightening and un-tightening.

d torque value torque wrench away.

Once the desiredis reached, the thandle will snap

4

Ratchet Functionality (Unlimited Torque)

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Drilling Sequence

The drilling sequence for OsseoLink implants typically begins with the round cortical perforation bur (REF RB6). This is followed by sequential drilling using twist drills of increasing diameter. Drills should be used with copious irrigation to prevent excessive generation of heat. Parallel pins (REF PPIN) and depth gauges (REF DEPG)are used between the different steps

Drilling sequence

for standard or soft bone

Drilling sequencefor hard

bone

S u r g i c a l P r o c e d u r e s

Ø 3.5 mmImplant

Ø 4.0 mmImplant

Ø 5.0 mmImplant

Ø 3.5 mmImplant

Ø 4.0 mmImplant

Ø 5.0 mmImplant

(Optional tap for Ø

3.5 mm

Implant (hard bone)

(Optional tap for Ø

4.0 mm

Implant (hard bone)

(Optional tap for Ø

5.0 mm

Implant (hard bone)

Roundbur

Ø 2.0 mm Drill

Ø 2.5 mm Drill

Ø 4.3 mm Drill

Ø 4.9 mm Drill

Ø 3.9 mm Drill

Ø 3.35 mm Drill

Roundbur

Ø 2.0 mm Drill

Ø 2.5 mm Drill

Ø 4.3 mm Drill

Ø 4.9 mm Drill

Ø 3.9 mm Drill

Ø 3.35 mm Drill

Drilling sequence for Ø 4.0 mm Implants

Drilling sequence for Ø 3.5 mm Implants

Drilling sequence for Ø 5.0 mm Implants

Suggested drilling speed only. Actual speed may vary depending on clinical situation.

Lindemann bur is optional prior to using the Ø 2.0 mm drill for both standard andhard bone.

Depth Gauge (REF DEPG)

to verify depth and angulation. A side cutting Lindemann bur is provided in the surgical kit and can be used prior to the Ø 2.0 mm drill. Depending on the type of bone, the clinician may choose to modify the drilling protocol. Countersink drills can also be used in areas where dense bone is encountered. Addition- ally, bone taps are available should tapping of the surgical site be deemed necessary.

NOTE: Images may not be to scale.

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The OctaCone Quad connection is the implant’s internal connection and is the universal prosthetic platform in this system. As the name implies, this connection has the following features:

• Internal conical recess that is 13° in taper providing excellent sealing at the implant abutment interface. This conical recess provides a “self-guiding” feature for easy installation of prosthetic components resulting in simplified clinical procedures. Addition- ally, the 13° taper allows the fabrication of splinted screw retained restorations on implants with diver- gence up to 26 degrees.

• A modified octagonal internal indexing feature that provides four distinct indexing positions. The combination of the conical recess and the modified octagonal feature provides a very stable connection that minimizes the stresses to the prosthetic screw.

As the single prosthetic platform, the OctaCone Quad connection greatly simplifies implant surgical and restorative procedures. Moreover, having a stable implant-abutment connection minimizes micromovement and microleakage which results in optimal peri-implant tissue health.

One implant driver (REF UID) is needed to install the implant into the prepared osteotomy.

A single prosthetic screw (REF UNIPS) is used throughout the implant system regardless of implant diameter.

One impression coping can be used with all implants in this system regardless of implant diameter.

A single laboratory analog (REF UNILA) is used by the laboratory technicians regardless of implant diameter.

O c t a C o n e ™ Q u a d C o n n e c t i o n

Impression Copings

Impression Copings

Features

OsseoLink impression copings are two-piece components designed for implant level impression technique. The impression coping is secured to the implant with the impression coping pin/screw. They are designed to transfer the exact position of the implant and the orientation of the OctaCone Quad connection to the dental laboratory. Impression copings are available in two lengths, long and short. The long impression coping has opposing flat and curved walls and a distinct undercut zone. These features provide secure anti-rotation and can be easily identified for accurate re-insertion into the impression when a closed-tray impression technique is used. The short impression coping has four flat walls for optimal anti-rotational features. The impression copings are designed for use with either open or closed tray impression technique. The same impression coping can be used with all three different implant diameters for increased simplicity.

Material

High quality stainless steel.

Installation

Impression coping is secured to the implant with the impression coping screw. The self-aligning feature of the OctaCone Quad connection ensures easy installation. Finger tightening or use of the 0.05" (1.25 mm) hex driver is recommended.

Finite Element Analysis (FEA)of implant abutment assembly

under oblique load.Note minimal stress transfer

to the prosthetic screw.

13° taperconical recess

Four distinctindexingpositions

Ø 3.5 mm Ø 4.0 mm Ø 5.0 mm

I m p r e s s i o n C o p i n g s

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Features

The laboratory analog is a replica of the implant for use in the dental laboratory. It replicates the critical features of the OctaCone Quad connection for proper indexing and positioning in the dental cast. The OctaCone Quad connection allows for the use of a single analog regardless of implant diameter, providing simplicity and reduced inventory needs. Several retentive and anti-rotational features are incorporated into the analog for secure locking into the stone cast.

Material

High quality stainless steel.

Installation

After the impression has been made, the laboratory analog is secured to the impression coping using the appropriate impression coping screw. The dental cast is fabricated according to standard laboratory procedures.

Only one analog is needed regardless of implant diameter.

Features

OsseoLink prosthetic screw is compatible with all implant sizes. It is used for fastening the abutments to the implants. Only one screw is needed regardless of implant diameter for simplicity and reduced inventory. The screw is designed with a 0.05" (1.25 mm) hexed recess for installation.

Material

Titanium Alloy (Ti6AI4V). Installation

Torque to 30–35 Ncm with 0.05" hex driver insert (REF HDH050) using OsseoLink Torque Wrench (REF ITWISO).

L a b o r a t o r y A n a l o g

P r o s t h e t i c S c r e w

A b u t m e n t S e l e c t i o n G u i d e

Removable Restorations

Titanium StraightAbutments(Anatomic)

Titanium StraightAbutments

(Non-anatomic)

Angled Titanium

Abutments

CustomAbutments

UCLA-non-engaging

Singleunit

Splinted or Bridge(Multiple)

UCLA-engaging

Ball abutments UCLA-non-engaging

Locator®

Abutments Ball-retained Bar-retained

Screw-retainedSingle or multiple units

Cement-retainedSingle or multiple units

Fixed Restorations

Overdentures

CAD/CAM

UCLA

Ø 3.5 mm Ø 4.0 mm Ø 5.0 mm

CAD/CAM

Lab Analog REF

Universal Implant Lab Analog UNILA

Prosthetic Screw

REF

Universal Prosthetic Screw UNIPS

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0.5mm

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Features

Straight Titanium Abutments are prefabricated abutments and can be anatomical or non-anatomical. The anatomical abutments feature a scalloped chamfer finish line and measure 4.5 mm or 5.5 mm at their widest circumference. The non- anatomical abutments feature a flat finish line and measure 4.5 mm, 5.5 mm, or 6.0 mm at their widest circumference. Both types of abutments can be modified to accommodate most prosthetic applications. The abutments are made of titanium alloy and feature the OctaCone Quad connection. Titanium nitride coating provides a warm golden color for improved esthetics. The abutments are compatible with all three implant diameters and are used with our Universal Prosthetic Screw (REF UNIPS).

Indications

• Cement retained single crown restorations.• Cement retained bridgework.

Installation

Use OsseoLink Universal Prosthetic Screw (REF UNIPS). Torque to 30 Ncm with 0.05" hex driver (REF HDH050) using OsseoLink Torque Wrench (REF ITWISO).

S t r a i g h t T i t a n i u m A b u t m e n t s

Features

Angled Titanium Abutments are prefabricated abutments with a 15° angulation to the long axis of the implant. They feature an anatomical chamfer finish line and can be customized through preparation to meet prosthetic needs. Two transgingival contours are offered for increased prosthetic flexibility for most clinical applications. The angled abutments have an octagonal connection that allows for eight different indexing positions. This provides the clinician with more options for angle correction when indicated. Titanium nitride coating provides a warm golden color for improved esthetics. Angled abutments are compatible with all three implant diameters of the OsseoLink system and are used with the Universal Prosthetic Screw (REF UNIPS).

A n g l e d T i t a n i u m A b u t m e n t s

Straight Titanium Abutments (Anatomical) REF Ø 4.5 mm Anatomic TI40 Ø 5.5 mm Anatomic TI50

Straight Titanium Abutments (Anatomical)

Straight Titanium Abutments (Non-anatomical)* REF

Ø 4.5 mm, 2.25 mm (H) TI40N

Ø 4.5 mm, 0.5 mm (H) TI40N0

Ø 4.5 mm, 4.0 mm (H) TI40N4

Ø 5.5 mm, 2.25 mm (H) TI50N

Ø 5.5 mm, 0.5 mm (H) TI50N0

Ø 5.5 mm, 4.0 mm (H) TI50N4

Ø 6.0 mm, 2.25 mm (H) TI60N

Indications

• Cement retained single crown restoration where angle correction is needed.• Cement retained bridgework where angle correction is needed.

Installation

Use OsseoLink Universal Prosthetic Screw (REF UNIPS).Torque to 30–35 Ncm with 0.05" hex driver (REF HDH050) using OsseoLink Torque Wrench (REF ITWISO).

Angled Abutments

REF

Ø 4.5 mm Angled Abutment ATI40

Ø 5.5 mm Angled Abutment ATI504.5 mm

4.5 mm4.5 mm

4.0mm

4.5 mm 5.5 mm 6.0 mm5.5 mm 5.5 mm

5.5 mm

4.5 mm

eded.

ersal

5.5 mm

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Straight Titanium Abutments (Non-anatomical)

TI40N TI40N0 TI40N4 TI50N TI50N0 TI50N4 TI60N

2.25mm

2.25mm

2.25mm

0.5mm 4.0

mm

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C a s t - t o a n d C a s t a b l e A b u t m e n t s

Features

The Cast-to and Castable Abutments are our UCLA-type prefabricated abutments. They offer the possibility to design a customized abutment for various prosthetic solutions using the traditional wax-up and casting technique. Engaging and non-engaging options are offered. The Cast-to Abutments are manufac- tured with a gold-platinum alloy base with a plastic burn-out sleeve and feature the OctaCone Quad connection. Castable abutments are made of an all resin material and do not have the indexing component of the Octacone Quad connection. They are therefore considered non-engaging abutments and are suitable for splinted units only. Both abutments are compatible with all three implant diameters of the OsseoLink system and are used with our Universal Prosthetic Screw (REF UNIPS).

Indications

• Custom abutment fabrication for cemented restorations (engaging).

• Screw-retained single crowns (engaging).

• Screw-retained fixed partial dentures (non-engaging).

• Bar-type restorations (non-engaging).

Installation

Use OsseoLink Universal Prosthetic Screw (REF UNIPS). Torque to 30–35 Ncm with 0.05" hex driver (REF HDH050) using OsseoLink Torque Wrench (REF ITWISO).

Cast-to and Castable Abutments

REF

Cast-to Abutment-Engaging UCLAGE Castable Abutment-Non-engaging UCLAPNE

Cast-to Abutment(Engaging)UCLAGE

Castable Abutment(Non-engaging)

UCLAPNE

Features

The ball abutments are designed as solid one-piece abutments for ball retained overdenture cases. The 13º tapered base engages the internal cone of the OctaCone Quad connection of the implant and provides a secure link.

Two different transgingival heights are available depending on tissue thickness.

The abutment can be used with all three implant diameters. The ball abutments are made out of titanium alloy and are provided with titanium nitride coating giving them a warm golden hue. The ball portion of the abutment is 2.5 mm in diameter and serves as the male portion of the ball attachment.

Indications

• Overdentures.

Installation

Torque to 15–20 Ncm with 0.05" hex driver (REF HDH050) using OsseoLink Torque Wrench (REF ITWISO).

Ball Abutments

REF

Ball Abutment 2.0 mm (H) BA20 Ball Abutment 4.0 mm (H) BA40

Ball Abutment Cap/O-rings CAPORI

O-rings set of 6 ORING

O v e r d e n t u r e A b u t m e n t s

Ball Abutment Cap and O-ring

A metal housing is used with the rubber O-ring. Multiple undercuts in the housing ensure secure retention of the housing in the denture base. The total vert ical height of the ball and the Cap/O-ring assembly is 3.1 mm.

3.1 mm

ORING(Set of 6 O-rings)

CAPORI(Includes 4 O-rings)

Ball Abutment(2.0 mm H)

BA20

Ball Abutment(4.0 mm H)

BA40

4.0 mm4.0

2.0 mm

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O v e r d e n t u r e A b u t m e n t s

LOCATOR® Abutments

LOCATOR Abutments for the OsseoLink system are provided in different transgingival heights. They offer the following advantages:

• LOWEST vertical height

• Patented DUAL retention

• Unique pivoting denture cap

• Use with non-parallel implants

CAD/CAM Solutions

CAD /CAM custom abutments are available in titanium and zirconium for all OsseoLink implants.

Abutments are designed using our modeling software and are custom manufactured for each case.

Our CAD /CAM solutions offer the ultimate flexibility in case design and precision machining that meet the demands of the most challenging cases. Custom abutments are engineered with the final restoration in mind for maximum functionality and esthetics.

Precision machining, unmatched turnaround time, and consistency are just a few of the many advantages. Laboratories and dentists can expect a pre-determined per unit cost regardless of market fluctuations.

Contact us for more details and ordering information of our custom CAD /CAM solutions.

01915/0 2777 01914/02776 01913/02775 01912/02774 01911/02773

Transgingivalheight 5.0

mm 4.0mm

1.5 mm

3.0mm 2.0

mm1.0 mm

LOCATOR is a trademark of Zest Anchors, LLC.

Locator Abutments

REF

Locator Abutment 1.0 mm (H) 01911/ 02773

Locator Abutment 2.0 mm (H) 01912/ 02774

Locator Abutment 3.0 mm (H) 01913/ 02775

Locator Abutment 4.0 mm (H) 01914/ 02776

Locator Abutment 5.0 mm (H) 01915/ 02777

Locator Core Tool 8393

Locator Male Processing Pkg (2 Pk) 8519–2

Extended Range Male Proc. Pkg (2 Pk) 8540–2

LOCATOR implant abutments should be ordered to the exact height of the gingival measurement (tissue depth) or round up to the next taller cuff height. Abutments will extend 1.5 mm above the tissue to allow the denture cap to snap on.

The LOCATOR Male Processing Package will provide you with a choice of retention. The LOCATOR Replacement Males (clear, pink, blue) can be used to restore an implant with up to 10 degrees of divergence (20 degrees between implants).

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O s s e o L i n k A l l o g r a f t s — C o r t i c a l a n d C a n c e l l o u s M i n e r a l i z e d C h i p s B u i l d i n g B r i d g e s t o S u c c e s s

Sterilization

Allografts are sterilized and processed using the DuraMatrix Supercritical CO2 Process.* This proprietary process enables sterilization while preserving the bio-mechanical properties of the graft material.

The typical shelf life of the product is 5 years. The packaging of all sterile products is inspected for flaws in the sterile barrier before opening. In the presence of such a flaw, the product is assumed non-sterile and returned immediately to the sterile barrier.

Donor Screening and Testing

Prior to tissue processing, the donor's medical and social histories are screened for medical conditions that would contraindicate the donation of tissues. All policies and procedures for donor screenings and serologic/microbiologic

testing meet current standards established by the American Association of Tissue Banks. Contraindications for tissue donation include: presence of infectious disease, neurological degen- erative disease, disease of unknown etiology and/or exposure to toxic substances. The donor's medical and social histories are also screened for HIV, hepatitis and other relevant communicable disease agents in accordance with current United States Public Health Services Recommendations and FDA regulations.

Testing of donor blood and tissue samples begins at the site of recovery and continues throughout processing. Donor blood samples taken prior to or at the time of recovery are tested by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and are determined negative using FDA licensed tests for:

• HBsAG – Hepatitis B Surface Antigen

• HBcAb (Total) – Hepatitis B Core Total

• HCV Ab – Hepatitis C Antibody

• HIV 1 /2 Ab – Antibody to Human Immunodeficiency Virus – Types I and II

• RPR/STS/FTA – Syphilis Detection

• HIV NAT – HIV Nucleic Acid Test

• HCV NAT – HCV Nucleic Acid Test

• HTLV I/II Ab – Human T-Lymph tropic Virus Types I and II

Biopsy core harvested with trephine drill

Bone core from grafted sinus

Photomicrograph of grafted bone core (H&E stain)

* US patent 7,108,832-SCCO2 Sterilization is a technology of NovaSterilis.OsseoLink Allografts are processed by Allograft Innovation, a US facility that is accredited by the American Association of Tissue Banks.

OsseoLink Allografts

A good foundation of healthy bone is essential for long term implant success. Many times, implant sites are in need of augmentation procedures. Whether it is a deficient ridge in need of grafting, a pneumatized maxillary sinus, or a dehiscence requiring management at the time of implant placement, OsseoLink Allografts offer a versatile grafting solution. A combination of mineralized cortical & cancellous bone chips of various dimensions that provide an osteoconductive scaffold for bone regeneration. The slow resorbing cortical particles are ideal for maintaining graft space and volume. The readily resorbed cancellous particles provide a favorable architecture for new bone formation by osteogenic progenitor cell. The mixture is available in a range of sizes for multiple regenerative solutions.

Clinical Applications

• Ridge augmentation procedures

• Sinus augmentation

• Socket preservation and grafting

• Periodontal defects

Particle Sizes

• 0.5–1.0 mm SEM photo of allograft particles

Allograts

REF

1.0 cc Cortical Cancellous Chips 0.5–1.0 mm SC0465AI

2.0 cc Cortical Cancellous Chips 0.5–1.0 mm SC0466AI

5.0 cc Cortical Cancellous Chips 0.5–1.0 mm SC0467AI

Pre-operative view of pneumatized left maxillary sinus

4 months post grafting (Note sinus graft in left maxillary sinus)

View of grafted maxillary sinus 4 months post op. (Note graft consolidation)

Photomicrograph showing new bone formation ���(������������� ����'����$����'��'������'��)(�%

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