EN paradigma - axelmed.com · Microstructured High Purity Surface (SAP) 2 Sandblasted small grit Acid etched triple attack Plasma Double treatment to reduce healing time.(2) Flat

paradigma

life from titanium

EN

“Everythingshould be made

as simple as possible, but not simpler.”

(Albert Einstein)

Sometimes I wonder what is our main objective?What fuels our perseverance and the constant pursuit of “I can do better”…

and what will the real reward to all ourefforts and commitment to this loved profession be?

…every day we recreate nature using knowledge,technology, materials, our hands…

maybe the best reward life can give us is a simple smile.

Our Mission

1

3

45

6

2

paradigma

04

Crestal or Subcrestalplacement

Axelmed® Paradigma®

EU Registered Design No 002938092-0001

®

life from titanium

References Bibliography(1) Cochrane Database Syst Rev. 2014 Jul 22;7(2) Int J Oral Maxillofac Implants, 2003; 18(5):659–66.(3) J Long Term Eff Med Implants. 2014;24(2-3):109-19.(4) Int J Oral Maxillofac Implants, 2013 May-Jun; 28(3) 815-23 (5) J Prosthet Dent. 2016 Sep - Systematic Review(6) Clin Oral Implants, Res 2010 feb; 21(2) 129-36

Machined Surface

1The surface with the lowest risk of developing peri-implantitis.(1)

Microstructured High Purity Surface (SAP)

2Sandblasted small gritAcid etched triple attack Plasma Double treatment to reduce healing time.(2)

Flat Apex

3Prevent accidental injury to noblestructures and create a betterstress and strain distribution.(3)

Back Tapered and Platform switching

4Greater amount of bone at the crest level and greater support for the soft tissue.(4)

Microthread

5Reduce stress and promote new boneformation.(5)

Optimized Thread Design

6Trapezoidal design with decreasing depth to optimize the primary stability.(6)

05

06

®

implant-prosthetic connection1

different implant design5

one

07

life from titanium

implant-prosthetic connection

different implant design

SAP surface: Sand-Blasting, Acid-Etching, Plasma Treatment

The presence of a machined surface in combination with microthreads, allows to reduce the risk of developing peri-implantitis without compro-mising the stability of marginal bone levels.

Implant Surface Identification Standard (ISIS) is a codification system developed by Dohan et al.* for the chemical and mor-phological characterization of dental implant surfaces. Follow-ing the Dohan protocol and us-ing the same type of analysis (performed by an external inde-pendent laboratory) we com-pared the surface of Axelmed®

Paradigma® with those of the main implant brands worldwide. In particular it’s important to take into account:• the percentage of pollution and contamination present on the sur-face (Bar Chart A).• the percentage of free exposed ti-tanium on the surface (Bar Chart B).

*David M. Dohan Ehrenfest et al.ISIS identification cards of 62 implant surfaces. Part 1 - POSEIDO. 2014;2(1) 7

The minimally-rough surface and micro geometry of the implant body are achieved by sand blasting with small grit of pure Al2O3, followed by a triple acid treatment. This roughness allows to accelerate the osteo-integration process.

The treatment with Plasma Argon, done before the process of gamma sterilization, allows for elimination of any organic residues on the implant surface and the adherent endotoxins. The only Gamma Ray sterilization treatment is able to kill the cellular components but it’s not capable of removing their structure and this could trigger inflammatory reactions by the host tissue.

All surface treatments are developed and made in our factory, following severe protocols and certified quality control.

17

%

Average

Alpha Bio SPI

Magitech MS2010Tecom Implantology REP

Dentsply Ankylos

Straumann Standard Plus (SLActive)Implant Direct SwissPlant

Anthogyr BCPNeodent Titamax Ti Ex (Neoporos)

MegaGen AnyRidge (Xpeed)MegaGen AnyRidge (Xpeed Plus)

Nobel Biocare Replace

Straumann Roxolid (SLActive)Cowellmedi Inno

BTI InternaBiohorizons RBT

Blue Sky Bio ActivFluor

DIO BioTite-M

Shinhung Luna (RBM+)Keystone Genesis

Thommen ElementOspol

BioSAF IN Winsix WMRSBredent blueSky

MIS Seven

Osstem RBM USIITekka In-Kone (SA2)

Camlog ScrewlineOsstem SA TSIII

Dentsply Xive S PlusSERF EVL Plus

Dentsply Frialit Plus

Straumann Standard Plus (SLA)Sweden&Martina Kohno (HRPS)

Dentium SuperLineAstraTech Osseospeed TX

Sweden&Martina Kohno (DES HRPS)GC Genesio Plus Re V

Biomet 3I OsseoTite 2

0 7,5 15 22,5

TITANIUM %

Bar Chart B

Axelmed Paradigma

AstraTech Osseospeed TXCowellmedi Inno

GC Genesio Plus Re VMIS Seven


Biomet 3I OsseoTite 2Neodent Titamax Ti Ex (Neoporos)

Anthogyr BCPBioSAF IN Winsix WMRS

Straumann Standard Plus (SLA)Dentsply Xive S Plus

Straumann Standard Plus (SLActive)Camlog Screwline

Nobel Biocare ReplaceOspol

SERF EVL PlusTekka In-Kone (SA2)

Bredent blueSkyOsstem RBM USII

Sweden&Martina Kohno (DES HRPS)Blue Sky Bio ActivFluor

Dentium SuperLineImplant Direct SwissPlant

Axelmed ParadigmaSweden&Martina Kohno (HRPS)MegaGen AnyRidge (Xpeed Plus)

Tecom Implantology REPMegaGen AnyRidge (Xpeed)

Straumann Roxolid (SLActive)Keystone Genesis

Alpha Bio SPIOsstem SA TSIII

Dentsply Frialit PlusDentsply Ankylos

Magitech MS2010DIO BioTite-M

Thommen ElementShinhung Luna (RBM+)

0 2,5

1,7

% 5 7,5 10

Average

Bar Chart A

POLLUTION %

3D Designing Acidification SAP Analysys Packaging

Precise Milling Dimensional Check Sandblasting Surface Checking

17

08


life from titanium


The presence of a machined surface in combination with microthreads, allows to reduce the risk of developing peri-implantitis without compro-mising the stability of marginal bone levels.

Implant Surface Identification Standard (ISIS) is a codification system developed by Dohan et al.* for the chemical and mor-phological characterization of dental implant surfaces. Follow-ing the Dohan protocol and us-ing the same type of analysis (performed by an external inde-pendent laboratory) we com-pared the surface of Axelmed®

Paradigma® with those of the main implant brands worldwide. In particular it’s important to take into account:• the percentage of pollution and contamination present on the sur-face (Bar Chart A).• the percentage of free exposed ti-tanium on the surface (Bar Chart B).

*David M. Dohan Ehrenfest et al.ISIS identification cards of 62 implant surfaces. Part 1 - POSEIDO. 2014;2(1) 7

The minimally-rough surface and micro geometry of the implant body are achieved by sand blasting with small grit of pure Al2O3, followed by a triple acid treatment. This roughness allows to accelerate the osteo-integration process.

The treatment with Plasma Argon, done before the process of gamma sterilization, allows for elimination of any organic residues on the implant surface and the adherent endotoxins. The only Gamma Ray sterilization treatment is able to kill the cellular components but it’s not capable of removing their structure and this could trigger inflammatory reactions by the host tissue.

All surface treatments are developed and made in our factory, following severe protocols and certified quality control.

17

%

Average

Alpha Bio SPI

Magitech MS2010Tecom Implantology REP

Dentsply Ankylos

Straumann Standard Plus (SLActive)Implant Direct SwissPlant

Anthogyr BCPNeodent Titamax Ti Ex (Neoporos)

MegaGen AnyRidge (Xpeed)MegaGen AnyRidge (Xpeed Plus)

Nobel Biocare Replace

Straumann Roxolid (SLActive)Cowellmedi Inno


Blue Sky Bio ActivFluor

DIO BioTite-M

Shinhung Luna (RBM+)Keystone Genesis

Thommen ElementOspol

BioSAF IN Winsix WMRSBredent blueSky

MIS Seven

Osstem RBM USIITekka In-Kone (SA2)

Camlog ScrewlineOsstem SA TSIII

Dentsply Xive S PlusSERF EVL Plus

Dentsply Frialit Plus

Straumann Standard Plus (SLA)Sweden&Martina Kohno (HRPS)

Dentium SuperLineAstraTech Osseospeed TX

Sweden&Martina Kohno (DES HRPS)GC Genesio Plus Re V

Biomet 3I OsseoTite 2

0 7,5 15 22,5

TITANIUM %

Bar Chart B

Axelmed Paradigma

AstraTech Osseospeed TXCowellmedi Inno

GC Genesio Plus Re VMIS Seven


Biomet 3I OsseoTite 2Neodent Titamax Ti Ex (Neoporos)

Anthogyr BCPBioSAF IN Winsix WMRS

Straumann Standard Plus (SLA)Dentsply Xive S Plus

Straumann Standard Plus (SLActive)Camlog Screwline

Nobel Biocare ReplaceOspol

SERF EVL PlusTekka In-Kone (SA2)

Bredent blueSkyOsstem RBM USII

Sweden&Martina Kohno (DES HRPS)Blue Sky Bio ActivFluor

Dentium SuperLineImplant Direct SwissPlant

Axelmed ParadigmaSweden&Martina Kohno (HRPS)MegaGen AnyRidge (Xpeed Plus)

Tecom Implantology REPMegaGen AnyRidge (Xpeed)

Straumann Roxolid (SLActive)Keystone Genesis

Alpha Bio SPIOsstem SA TSIII

Dentsply Frialit PlusDentsply Ankylos

Magitech MS2010DIO BioTite-M

Thommen ElementShinhung Luna (RBM+)

0 2,5

1,7

% 5 7,5 10

Average

Bar Chart A

POLLUTION %

3D Designing Acidification SAP Analysys Packaging

Precise Milling Dimensional Check Sandblasting Surface Checking

17

09


OBJECTIVES

MATERIAL AND METHODS

RESULTS

DISCUSSION

OBJ

MATAA

JECTIVES RESULTSLL

TTERIAL AND METHODS

DISCUSSION

General Data Torque Value Distribution

In the period between November 2014 and April 2016, 29 patients received consecutively a total of 93 Axelmed® Paradigma® by different operators with different levels of surgical skills. Of the 93 implants, 39 (41.9%) were loaded immediately, while the remaining 54 (58,1%) were loaded 10 weeks after the place-ment. 63 (67.7%) Axelmed® Paradigma® implants were used in a one-step technique, while the remaining 30 (32.3%) received a two-phase approach.Torque insertion was evaluated, postoperative Rx were taken at T0 (immediately after surgery), T1 (1 month), T2 (3 months), T3 (1 year) and the follow up was between 4 and 16 months.

2 implants (2.1%) failed, both in the maxilla, both placed immediately after tooth extraction and both treated with an immediate loading protocol where the initial insertion torque was 50 Ncm in presence of a III Class bone quality (Lekholm and Zarb, 1985). 23 implants (24.7%) were placed in post-extraction sockets, while 70 (75.3%) were in healed sites. The 93 Axelmed® Paradigma® received an initial torque with its distribution summarized in the bar graph. These values were recorded using the surgical motor Intrasurgery 2.0.

Literature data indicate that it’s desirable to reach a minimum value of 35 Ncm to proceed with an immediate loading protocol. However, some authors advise against using very high torque values (above 70 Ncm) to avoid possible necrosis around the implant fixture. The data and the experience in this report indicate the possibility to achieve good levels of primary stability using Axelmed® Paradigma® dental implants that respect bone tissue biology and surrounding structures.The implant thread design (trapezoidal with decreasing depth) and the conical shape of the body allowed to achieve a good primary stability. This is the main objective for the clinicians dealing with immediate loading protocol during their activity. Effectively, this implant design appears to demonstrate in almost 84% of the cases an excellent primary stability with > 35 Ncm torque insertion.

Post-Extraction sitesHealed Sites

75,3% 24,7%

44,1% 55,9%

MaxillaryMandibular

Patients

Implants

Implants Failure

Maxillary

Mandibular

One-Step Technique

Post-Extraction Sites

Healed Sites

Immediate Loading

Delayed Loading Torque(Ncm)

29 70

Implantsnumber

35

0

52

17

93

2

52

41

30

23

70

39

54

2,1%

55,9%

44,1%

Two-Steps Technique

63 67,7%

32,3%

24,7%

75,3%

41,9%

58,1% < 20 20 < 35 35 < 50 > 50

Obtaining a good primary stability is one of the main objectives during a dental implant place-ment procedure and the specific geometries for each Axelmed® Paradigma® diameter were developed to satisfy this requirement. The present report aims at analysing this feature in different clinical conditions.

10

A prospective study on the evaluation of primary stability of Axelmed® Paradigma®

OBJECTIVES

MATERIAL AND METHODS

RESULTS

DISCUSSION

OBJ

MATAA

JECTIVES RESULTSLL

TTERIAL AND METHODS

DISCUSSION

General Data Torque Value Distribution

In the period between November 2014 and April 2016, 29 patients received consecutively a total of 93 Axelmed® Paradigma® by different operators with different levels of surgical skills. Of the 93 implants, 39 (41.9%) were loaded immediately, while the remaining 54 (58,1%) were loaded 10 weeks after the place-ment. 63 (67.7%) Axelmed® Paradigma® implants were used in a one-step technique, while the remaining 30 (32.3%) received a two-phase approach.Torque insertion was evaluated, postoperative Rx were taken at T0 (immediately after surgery), T1 (1 month), T2 (3 months), T3 (1 year) and the follow up was between 4 and 16 months.

2 implants (2.1%) failed, both in the maxilla, both placed immediately after tooth extraction and both treated with an immediate loading protocol where the initial insertion torque was 50 Ncm in presence of a III Class bone quality (Lekholm and Zarb, 1985). 23 implants (24.7%) were placed in post-extraction sockets, while 70 (75.3%) were in healed sites. The 93 Axelmed® Paradigma® received an initial torque with its distribution summarized in the bar graph. These values were recorded using the surgical motor Intrasurgery 2.0.

Literature data indicate that it’s desirable to reach a minimum value of 35 Ncm to proceed with an immediate loading protocol. However, some authors advise against using very high torque values (above 70 Ncm) to avoid possible necrosis around the implant fixture. The data and the experience in this report indicate the possibility to achieve good levels of primary stability using Axelmed® Paradigma® dental implants that respect bone tissue biology and surrounding structures.The implant thread design (trapezoidal with decreasing depth) and the conical shape of the body allowed to achieve a good primary stability. This is the main objective for the clinicians dealing with immediate loading protocol during their activity. Effectively, this implant design appears to demonstrate in almost 84% of the cases an excellent primary stability with > 35 Ncm torque insertion.

Post-Extraction sitesHealed Sites

75,3% 24,7%

44,1% 55,9%

MaxillaryMandibular

Patients

Implants

Implants Failure

Maxillary

Mandibular

One-Step Technique

Post-Extraction Sites

Healed Sites

Immediate Loading

Delayed Loading Torque(Ncm)

29 70

Implantsnumber

35

0

52

17

93

2

52

41

30

23

70

39

54

2,1%

55,9%

44,1%

Two-Steps Technique

63 67,7%

32,3%

24,7%

75,3%

41,9%

58,1% < 20 20 < 35 35 < 50 > 50

Obtaining a good primary stability is one of the main objectives during a dental implant place-ment procedure and the specific geometries for each Axelmed® Paradigma® diameter were developed to satisfy this requirement. The present report aims at analysing this feature in different clinical conditions.

life from titanium

11

A prospective study on the evaluation of primary stability of Axelmed® Paradigma®

Lazzari P. * Private Practice, Milan, Italy

Dr. Piero Lazzari • Chief Scientific Adviser • Milano

Post extraction implant placement with immediate loading

Zirconia Full-Arch implant supported rehabilitation with Axelmed® Paradigma® implants


12

Post extraction implant placement with delay loading

Full mouth rehabilitation implants Overdenture using ball-attachment system



13

Courtesy of Dr. Luigi Bernardini • Fermo • Italy

Courtesy of Dr. Daniele Camerucci • Rome • Italy

14

Rehabilitation of edentolous maxilla in combination withGBR technique

Placement of four implants in intraforaminal region usingautogenous bone as a graft material

Courtesy of Dr. Salvatore Terlizzi • Gravina • Italy

Courtesy of Dr. Davide Casella • Milan • Italy

15

Axelmed® Paradigma® implant placement in combination withbone graft and vertical sinus lift (Summer’s Technique)

Axelmed® Paradigma® implant placement in posterior Maxilla

16

Axelmed® Abutments

Together, the combi-ned application of platform switching and concave design for the emergence profile, represent the way to increase the amount of soft tissue around implants and to pro-mote:

• elimination of exces-sive abutment pressu-re on gingival tissue adjacent to implants;

• sufficient interproxi-mal space between implant and adjacent tooth/implant for the entry of interproximal toothbrush;

• elimination of exces-sive soft tissue blan-ching during abutment seating at prosthesis delivery.

Grooves to easily cut the extended external lenght (9 mm) to augment cement retention and as coded-system toidentify the emergence profile diameter

Flat surfacefor “closed tray implant impression technique

ProstheticEmergence Profile

Round internal anglefor zirconia restorations

Platform Switching to preserve marginal bone level

The same Emergence Profile between abutments and

healing abutments

life from titanium

Axelmed® Abutments

Grooves to easily cut the extended external lenght (9 mm) to augment cement retention and as coded-system toidentify the emergence profile diameter

Flat surfacefor “closed tray implant impression technique

Round internal anglefor zirconia restorations

17

The same Emergence Profile between abutments and

healing abutments

Number of grooves indicate the diameter of the emergence profile

4 mm5 mm

6 mm

18

Bone Regeneration Drill

Autologous bone, thanks to its capacity of osteogenesis, oste-oinduction and osteoconduction is, nowadays, the gold standard in bone regeneration.

Axelmed® Bone Regeneration Drill (BRD) allows for the collection of autologous bone chips during the osteotomy for the preparation of the implant sites and to perform small GBR (Guided Bone Regeneration) procedure without recourse to heterologous/homologous graft.

This means:• lower risk of post-operativecomplications;

• financial savings;

Enlargement for universal depth stop

Hole for the collection of autologous bone

Excellent cutting power

Apical shrinkage to improve primary stability

19

Easy Surgical TrayA focused, ergonomic, not superflous kit.

Easy opening and storage.Axelmed Pack®

20

A Healing Screw • B Closure Screw • C Paradigma® Implant

1 Lab Screw • 2 Lab Analog • 3 Calcinable Abutment

4 Esthetic Abutment • 5 Plastic Impression Transfer • 6 Definitive Screw

1

A

4

2

B

5

3

C

6

®

ALL-in-ONEAxelmed

life from titanium

21

A way to solve 80% of cases by ordering just 1 code

(more efficient, more precise, more convenient)

ALL-in-ONE kit includes all the components for the procedure

Immediate loading

CementRetained

CementRetained

CementRetained

CementRetained

ScrewRetained

ScrewRetained

ScrewRetained

ScrewRetained

Delayed loading

Temporary Crown

Temporary Crown

Temporary Crown

Definitive Crown

Definitive Crown

Definitive Crown

22

Kit ALL-in-ONE

Description Ø

Bulk PackagingQ.ty

3,4 3,4 3,4 3,4

3,8 3,8 3,8 3,8

4,3 4,3 4,3 4,3 4,3

5,0 5,0 5,0 5,05,0

5,6 5,6 5,6

200500800

Height

Description

9mm11mm13mm15mm

9mm11mm13mm15mm

7mm9mm11mm13mm15mm

7mm9mm11mm13mm15mm

7mm9mm11mm

assorted All-in One KITassorted All-in One KITassorted All-in One KIT

Code

Code

81104811058110681107

81108811098111081111

8111281113811148111581116

8111781118811198112081121

811228112381124

BA200BA500BA800

Axelmed Paradigma implant system

ALL-in-ONE Kit contains 1x

• Paradigma® Implant• Titanium closure cap• Titanium healing cap*• Plastic transfer (closed tray technique)• 0° Esthetic abutment transmucosal h 1,8 mm*• Definitive abutment screw gold-colour• Plastic castable abutment• Implant laboratory analog• Laboratory abutment screw blue-colour

(*size vary with implant diameter)

ALL-in-ONE Kit sample

(choice of sizes)

® ®

23

Paradigma® Implant with closure cap and healing cap

Description 7mm 9mm 11mm 13mm 15mm Height

9mm11mm13mm15mm

9mm11mm13mm15mm

7mm9mm11mm13mm15mm

7mm9mm11mm13mm15mm

7mm9mm11mm

Code

82104821058210682107

82108821098211082111

8211282113821148211582116

8211782118821198212082121

821228212382124

Paradigma®

Implant Ø 3,4

Paradigma® Implant Ø 3,8




Ø 4mm emergenceprofile Healing Cap





Paradigma® implants scale 1:1.5

Bulk PackagingQ.ty

200500800

Description

assorted Implantsassorted Implantsassorted Implants

Code

BS200BS500BS800

(choice of sizes)

Ø 6mm emergence

Ø 6mm emergence

Ø 5mm emergence

Ø 4mm emergence

Ø 4mm emergence

24

Healing Cap

Description Emergence profile Height Code

Closure Cap

Healing Cap

Healing Cap

Healing Cap

Ø 4mm

Ø 5mm

Ø 6mm

020mm

3mm5mm7mm

3mm5mm7mm

3mm5mm7mm

-

4,04,04,0

5,05,05,0

6,06,06,0

82001

820028200382004

820058200682007

820088200982010

life from titanium

25

02

Impression components

Description Code

Implant abutment analog

Engaging transfer with Short screw

Engaging transfer with Long screw

Plastic extension tube for transfer (10 pcs)

Plastic transfer (closed tray technique)

83001

83003

83004

83005

83006

26

Temporary Abutment

Description Code

Non-Hexed temporary abutment with blue screw

Hexed temporary abutment with blue screw

Non-Hexed plastic castable abutment with blue screw

Hexed plastic castable abutment with blue screw

Dental laboratory abutment screw (blue-colour)

83007

83008

83009

83010

83019

life from titanium

0° Esthetic abutmentwith gold screw



30° Estheticabutmentwith gold screw

Universal connector base with gold screw

Definitive abutment screw (gold-colour)

27

Definitive Abutment

Description Transmucosal h Profile Ø Code

456

456

55

55

-

-

1,8mm1,8mm1,8mm

2,8mm2,8mm2,8mm

1,8mm2,8mm

1,8mm2,8mm

-

-

830118301283013

830148301583016

8302083021

8302283023

83017

83018

28

Multi-Unit components

Description Height Profile Ø Code

0° Multi-Unit screwable

17° Multi-Unit with screw

30° Multi-Unit with screw

Laboratory analog for Multi-Unit abutment

Non-Hexed transfer for Multi-Unit abutment

Titanium Sleeve for Multi-Unit abutment

Castable Sleeve for Multi-Unit abutment

Healing cupfor Multi-Unit abutment

Prosthetic screw forMulti-Unit abutment (Sleeve)

Abutment screw forMulti-Unit (Implant)

Screwdriver for 0°Multi-Unit abutment

---

--

--

-

-

-

-

-

-

-

-

1,5mm3,0mm4,0mm

2,5mm4,0mm

3,5mm5,0mm

-

-

-

-

-

-

-

830248302583026

8302783046

8302883047

83002

83045

83043

83044

82011

83029

83048

85019

life from titanium

29

Ball Abutments

Description Height Profile Ø Code

Ball Abutmentsnormo Ø 2.5mm

Elastic cap for Ball AbutmentGreen • Very Elastic 350 gr. (6pcs.)

Elastic cap for Ball AbutmentYellow • Extra Soft 500 gr. (6pcs.)

Elastic cap for Ball AbutmentPink • Soft 900 gr. (6pcs.)

Elastic cap for Ball AbutmentClear • Standard 1300 gr. (6pcs.)

Elastic cap for Ball AbutmentBlack • Laboratory (6pcs.)

Metal Container for Elastic cap (6 pcs.)

Metal Transferfor Ball Abutment

Instrument for Ball Abutment(double side: applicator + extractor)

Laboratory analog forBall Abutments

4,04,04,04,0

-

-

-

-

-

-

-

-

-

1mm3mm5mm7mm

-

-

-

-

-

-

-

-

-

83031830328303383034

83035

83036

83037

83038

83039

83040

83041

83042

83030

30

Surgery Kit

Description

Description

SURGERY KIT COMPONENTS

SURGERY KIT

Complete Surgery Kit

Q.ty Code

Code

86001P

Complete Surgery Kit

Empty Surgery Box

Surgical Organizer

Pilot DrillDrill twisted 2,0 mmDrill twisted 2,4 mmDrill BRD 2,8 mmDrill BRD 3,2 mmDrill BRD 3,6 mmDrill BDR 4,0 mmDrill BDR 4,4 mmDrill BDR 4,8 mmDrill BDR 5,2 mmDrill Cortical 3,4 mmDrill Cortical 3,8 mmDrill Cortical 4,3 mmDrill Cortical 5,0 mmDrill Cortical 5,6 mmDrill extenderDrill stop 7 mmDrill stop 9 mmDrill stop 11 mmDrill stop 13 mmDrill stop 15 mmTissue Punch 3,4 mmTissue Punch 4,3 mmManual screwdriver ShortManual screwdriver MediumManual screwdriver LongMachine Implant driver ShortMachine Implant driver LongParallel pinImplant Torque Wrench with ReverseManual Implant driver ShortManual Implant driver LongImplant distance indicatorMachine screwdriver ShortMachine screwdriver LongEmpty Surgery BoxSurgical Organizer (Alluminium)

11111111111111111111111111114111 11111

84001840028400384004840058400684007840088400984010840118401284013840148401584016840178401884019840208402185001850028500785008850098501085011850138501785015850168501885046850478600286003

life from titanium

31

Pilot Drill

Drill twisted

Drill BRD

Drill Cortical

Drill extender

Drill Stop

Surgery Drills

Description CodeHeight mm Ø mm

7 9 11 13 15

7 9 11 1315

84001

84002

84003

84004

84005

84006

84007

84008

84009

84010

84011

84012

84013

84014

84015

84016

84017

84018

84019

84020

84021

1,6

2,0

2,4

2,8

3,2

3,6

4,0

4,4

4,8

5,2

3,4

3,8

4,3

5,0

5,6

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

7

9

11

13

15

32

Tissue Punch

Manual screwdriver ShortManual screwdriver MediumManual screwdriver Long

Machine screwdriver ShortMachine screwdriver Long

Machine Implant driver ShortMachine Implant driver Long

Manual Implant driver ShortManual Implant driver Long

Surgery Instruments

Description CodeØ mm

8500185002

850078500885009

8504685047

8501085011

8501585016

3,44,3

life from titanium

Parallel pin

Implant Distance Indicator

Implant Torque wrench

Implant Torque wrench with reverse (0-50 Ncm)

33

Surgery Instruments

CodeDescription

22 Ncm 42 Ncm

32 Ncm 50 Ncm

72 Ncm

85013

85018

85014

85017

Temporary Abutment

Abutment

Abutment

ClosureCap

Healing Cap

ScrewsHealing cup


Impressioncomponents

Impression comp.

Laboratory components



Multi Unit Components

Overdenture

Surgery Drills

Surgery Instruments

ScrewConnector

Esthetic Abutment

Diameter Ø

3,4

3,8

4,3

5,0

5,6

Height mm

9111315

9111315

79

111315

79

111315

79

11

Code

Implant All-in-One

Code

81104811058110681107

81108811098111081111

8111281113811148111581116

8111781118811198112081121

811228112381124

83007

83006 83005 83001

83043 83044 83002

83019

8304882011 83029

8301883017

83011830148301283015

8302083021

8301383016

8302283023

Ø4 • h1,8Ø4 • h2,8Ø5 • h1,8Ø5 • h2,8

Ø5 • h1,8Ø5 • h2,8

Ø6 • h1,8Ø6 • h2,8

830248302583026

h 1,5h 3,0h 4,0

830318303283033 83034

8303583036830378303883039

Green • Very Elastic 350 gr. (6pcs.)

Yellow • Extra Soft 500 gr. (6pcs.)

Pink • Soft 900 gr. (6pcs.)

Clear • Standard 1300 gr. (6pcs.)

Black • Laboratory (6pcs.)83030 83041 8304283040

h 1,0h 3,0h 5,0h 7,0

8302783046

8302883047

h 2,5h 4,0

h 3,5h 5,0

Ø5 • h1,8Ø5 • h2,8

83003

83004long screw

short screw

83045

82104821058210682107

82108821098211082111

8211282113821148211582116

8211782118811198212082121

821228212382124

Non-HexedTitanium

Closed traytechnique

Ball Abutment

PilotDrill

Man

ual s

crew

driv

er

Tiss

ue P

unch

Mac

hine

scr

ewdr

iver

Mac

hine

impl

ant d

rive

r

Man

ual i

mpl

ant d

rive

r

Par

alle

l pin

Scre

w D

rive

r fo

r 0°

Mul

ti U

nit A

butm

ent

Impl

ant D

ista

nce

Indi

cato

r

Surg

ery

Kit

Surg

ical

Org

aniz

er

Drills twisted Drills BRD Drills Cortical Drill extender Drill Stop

Elastic Cap Metal Containerfor Elastic Cap 6pcs.)

Transfer for Ball Abutment

Implant analog

Titanium sleeve Castable Sleeve Lab analog

Lab AbutmentScrew

DefinitiveScrew

Universal Connector Base

0° 0°

0°

0°

0°

0°

0°

15° 15° 30°15°

17°0°

Ø 4 Ø 5 Ø 6

30°30°

30°

Engaging transfer

Non-Hexed Transfer

820028200382004

84004840058400684007840088400984010

8401184012840138401484015

8400284003

86001 Complete86002 Empty

84001 84016

85007 85008 85015 85013 85019 85018 85014

N/cm2232425072

85017 8600385046 8501085009 8501685047 85011

840178401884019840208402182001

820058200682007

820088200982010

h 3,0h 5,0h 7,0

Ø 2,8Ø 3,2Ø 3,6Ø 4,0Ø 4,4Ø 4,8Ø 5,2

Ø 3,4Ø 3,8Ø 4,3Ø 5,0Ø 5,6

Ø 2,0Ø 2,4

Ø 1,6

h 7,0h 9,0h 11h 13h 15

h 3,0h 5,0h 7,0

h 3,0h 5,0h 7,0

0 15 30

83008

Hexed Titanium

17 30

401

504504

Instruments for Ball Abutment

(double side:applicator + extractor)

83010

Indi

cato

r

7 9 11 1315

83041

s.) Ball Abutment B

El tti 35000 83035

ed

Implant Sleeve

85001Ø 3,4

85002Ø 4,3

(double side:pplicator + extractor)

ta

Plastic extension tubefor transfer(10 pcs.)

7

83009

Non-HexedPlastic Castable

HexedPlastic Castable

paradigmaReference

Table

Impl

ant t

orqu

e w

renc

h

Impl

ant t

orqu

e w

renc

hw

ith r

ever

se

Laboratory analogfor Ball Abutments

34

Drills BRd

Temporary Abutment

Abutment

Abutment

ClosureCap

Healing Cap

ScrewsHealing cup


Impressioncomponents

Impression comp.




Multi Unit Components

Overdenture

Surgery Drills

Surgery Instruments

ScrewConnector

Esthetic Abutment

Diameter Ø

3,4

3,8

4,3

5,0

5,6

Height mm

9111315

9111315

79

111315

79

111315

79

11

Code

Implant All-in-One

Code

81104811058110681107

81108811098111081111

8111281113811148111581116

8111781118811198112081121

811228112381124

83007

83006 83005 83001

83043 83044 83002

83019

8304882011 83029

8301883017

83011830148301283015

8302083021

8301383016

8302283023

Ø4 • h1,8Ø4 • h2,8Ø5 • h1,8Ø5 • h2,8

Ø5 • h1,8Ø5 • h2,8

Ø6 • h1,8Ø6 • h2,8

830248302583026

h 1,5h 3,0h 4,0

830318303283033 83034

8303583036830378303883039

Green • Very Elastic 350 gr. (6pcs.)

Yellow • Extra Soft 500 gr. (6pcs.)

Pink • Soft 900 gr. (6pcs.)

Clear • Standard 1300 gr. (6pcs.)

Black • Laboratory (6pcs.)83030 83041 8304283040

h 1,0h 3,0h 5,0h 7,0

8302783046

8302883047

h 2,5h 4,0

h 3,5h 5,0

Ø5 • h1,8Ø5 • h2,8

83003

83004long screw

short screw

83045

82104821058210682107

82108821098211082111

8211282113821148211582116

8211782118811198212082121

821228212382124

Non-HexedTitanium

Closed traytechnique

Ball Abutment

PilotDrill

Man

ual s

crew

driv

er

Tiss

ue P

unch

Mac

hine

scr

ewdr

iver

Mac

hine

impl

ant d

rive

r

Man

ual i

mpl

ant d

rive

r

Par

alle

l pin

Scre

w D

rive

r fo

r 0°

Mul

ti U

nit A

butm

ent

Impl

ant D

ista

nce

Indi

cato

r

Surg

ery

Kit

Surg

ical

Org

aniz

er

Drills twisted Drills BRD Drills Cortical Drill extender Drill Stop

Elastic Cap Metal Containerfor Elastic Cap 6pcs.)

Transfer for Ball Abutment

Implant analog

Titanium sleeve Castable Sleeve Lab analog

Lab AbutmentScrew

DefinitiveScrew

Universal Connector Base

0° 0°

0°

0°

0°

0°

0°

15° 15° 30°15°

17°0°

Ø 4 Ø 5 Ø 6

30°30°

30°

Engaging transfer

Non-Hexed Transfer

820028200382004

84004840058400684007840088400984010

8401184012840138401484015

8400284003

86001P Complete 86002 Empty

84001 84016

85007 85008 85015 85013 85019 85018 85014

N/cm2232425072

85017 8600385046 8501085009 8501685047 85011

840178401884019840208402182001

820058200682007

820088200982010

h 3,0h 5,0h 7,0

Ø 2,8Ø 3,2Ø 3,6Ø 4,0Ø 4,4Ø 4,8Ø 5,2

Ø 3,4Ø 3,8Ø 4,3Ø 5,0Ø 5,6

Ø 2,0Ø 2,4

Ø 1,6

h 7,0h 9,0h 11h 13h 15

h 3,0h 5,0h 7,0

h 3,0h 5,0h 7,0

0 15 30

83008

Hexed Titanium

17 30

401

504504

Instruments for Ball Abutment

(double side: applicator + extractor)

83010

Indi

cato

r

7 9 11 1315

83041

s.) Ball Abutment B

El tti 35000 83035

ed

Implant Sleeve

85001Ø 3,4

85002Ø 4,3

(double side: pplicator + extractor)

ta

Plastic extension tubefor transfer(10 pcs.)

7

83009

Non-HexedPlastic Castable

HexedPlastic Castable

paradigmaReference

TableIm

plan

t tor

que

wre

nch

Impl

ant t

orqu

e w

renc

hw

ith r

ever

se

Laboratory analogfor Ball Abutments

35

Drills BRDrills BRDrills BRD DD D

Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4

7-9-11

7-9-11-13-15

7-9-11-13-15

9-11-13-15

9-11-13-15

CompatibleInternal HexStandard

Implantdiameter Drills Diameter

2.02.4 2.8 2.8

2.8 2.8 2.8

2.8 2.8 2.83.2

2.83.64.0 4.4 4.4

3.6 3.62.8 2.8

4.43.62.8

4.44.8 5.2

3.62.8

4.43.62.8

3.6 3.6

3.2 3.2

C1

C2

C3

C4

C5

2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

Drills Diameter

Sterile

Batch code

Catalogue number

Serial number

Re-use is not allowed

Do not resterilize

Manufacturer

Use by date

Manufacturing date CE logo Notified Boby ID Number

Non sterile

Do not expose to sunlight

Not to be used in case package is damaged

Read usage instructions

Caution, consult documents

Temperature limitation

Drills Diameter

Soft Bone(Type IV)

Medium Bone(Type II - III)

Hard Bone

ImplantDiameter

ProstheticConnection

Lenght (mm)

(Type I)

Type IV

Type III

Type II

Type I from 800 to 1200 rpm

from 400 to 800 rpm

from 250 to 650 rpm

from 250 to 650 rpm

Bone density Drilling speed (rpm)

Axelmed Paradigma® Implant

Healing Abutment

Abutment screw

Multi Unit screw

Ball Abutment

Max 60 Ncm

Max 10 Ncm

Max 32 Ncm

Max 15 Ncm

Max 32 Ncm

Component Torque Value

Symbols CEN/ISO and Legend:

Surgical Drill Protocol

Caution: Federal law restricts this deviceto sale by or on the order of a dentist

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16REF

RxOnly

xxxx

LOT

SN 17

36

GENERAL INFORMATIONSThe AXELMED® implant line can be used exclusively by qualified Doctors and Dentists. The AXELMED® products are CE certified medical devices (93/42/ EEC).

AXELMED® PARADIGMA® implant lines act as anchors for crowns, bridges or prostheses to the bone (both the upper and the lower jaw). They have an internal hexagonal connection, a conical body with two principle threads and are made of titanium Gr. 4 in accordance with the requirements of ISO 5832-2. AXELMED® PARADIGMA® implants are present in 5 different diameters with the same prosthetic connection (see the table below). The surface ofthe fixture is machined at the portion of the collar and micro-roughed atthe level of the body by SAP treatment (sandblasting with Al2O fine-grit,double Acidification, double decontamination with Argon Plasma). Thesurgical positioning of the implant is at the crestal or subcrestal bone level. It is packaged in a titanium cylinder protected by two sealed sterile tubesand a cover and a healing screw are to be found in the same packaging. It is sterilized by Gamma Ray irradiation (min 25kGy) and it is “STERILE” *(io direi: *sterilization lasts)until expiration date.

SURGICAL DRILLS The BRD drill (Bone Regeneration Drill) is used for the preparation of the implant bed. It presents a cavity to collect the bone, it must be used with sterile physiological solutions within 45-46 °C and the collected bone should be saved through a sterile spatula.

It is recommended to follow the protocol for the preparation of the implant site and to respect the rotational speed in relation to the bone density (see the table below). It is recommended to replace the BRD drills after about twenty times. Packaging: “NOT STERILE”.

PROSTHETIC COMPONENTSThe prosthetic components AXELMED® are made of titanium (Gr.5) according to ISO 5832-2. They include a wide range of devices (rights abutments, angled abutments, castable abutments, etc…) useful for the realization of temporary and definitive prosthesis. The prosthetic procedure is complex and highly specialized, so the clinician must have completed appropriate training courses and any prosthetic procedure must be the result of a proper diagnostic evaluation. Incorrect procedures or the use of non-original prosthetic parts can cause loss of the implant and biological damage. Wrapping: “NOT STERILE”.

TORQUE WRENCH AXELMED® torque wrenches are designed for the manual installation of the implant and the prosthetic components through default values of torque (see the table below). Packaging: “NOT STERILE”.

INSTRUMENTSBefore use, the “NON STERILE” instruments should be cleaned with hot water, disinfected, rinsed with distilled water, dried and sterilized. Do not use acids or harsh chemicals. The recommended sterilization method is with Autoclave Class B steam cycle with a temperature lower than 134°C (273°F) for 30 minutes. Instruments with signs of wear shouldn’t be used. Keep products in a closed and dry environment at room temperature (15-35° C/ 59-95 ° F). The disposal of products after use must be performed in accordance with the regulations on special waste.

WARRANTYThe warranty covers all parts that have production flaws proven before their use. Damage from improper use or caused by the use of non-original components are not covered by warranty. Any requests for damages can never exceed the average product price.

CAUTION: These general guidelines do not replace the User Manual (IFU) product specifications, nor the Axelmed Surgical and Prosthetic Guide, both available on the website www.axelmed.com or upon request to your distributor. Each product bears the main information on the packaging (see legend): Manufacturer: AXELMED SRL • Via Liberazione, 58 • EN 20098 S. Giuliano (MI) / Italy. ISO 9001 and ISO 13485. FDA Registered Brand.Axelmed® and Paradigma® are registered trademarks. ©Copyright 2016 AXELMED SRL

Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4Ø5.6

Ø5.0

Ø4.3

Ø3.8

Ø3.4

7-9-11

7-9-11-13-15

7-9-11-13-15

9-11-13-15

9-11-13-15

CompatibleInternal HexStandard

Implantdiameter Drills Diameter

2.02.4 2.8 2.8

2.8 2.8 2.8

2.8 2.8 2.83.2

2.83.64.0 4.4 4.4

3.6 3.62.8 2.8

4.43.62.8

4.44.8 5.2

3.62.8

4.43.62.8

3.6 3.6

3.2 3.2

C1

C2

C3

C4

C5

2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

2.0 2.0 2.0

Drills Diameter

Sterile

Batch code

Catalogue number

Serial number

Re-use is not allowed

Do not resterilize

Manufacturer

Use by date

Manufacturing date CE logo Notified Boby ID Number

Non sterile

Do not expose to sunlight

Not to be used in case package is damaged

Read usage instructions

Caution, consult documents

Temperature limitation

Drills Diameter

Soft Bone(Type IV)

Medium Bone(Type II - III)

Hard Bone

ImplantDiameter

ProstheticConnection

Lenght (mm)

(Type I)

Type IV

Type III

Type II

Type I from 800 to 1200 rpm

from 400 to 800 rpm

from 250 to 650 rpm

from 250 to 650 rpm

Bone density Drilling speed (rpm)

Axelmed Paradigma® Implant

Healing Abutment

Abutment screw

Multi Unit screw

Ball Abutment

Max 60 Ncm

Max 10 Ncm

Max 32 Ncm

Max 15 Ncm

Max 32 Ncm

Component Torque Value

Symbols CEN/ISO and Legend:

Surgical Drill Protocol

Caution: Federal law restricts this deviceto sale by or on the order of a dentist

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16REF

RxOnly

xxxx

LOT

SN 17

Disclaimers

Axelmed® Dental Implant System components are medical devices under the 93/42/CEE directives. AXELMED Company is a certified company ISO 13485 and fulfills the requirements ISO 9001.

Paradigma® Line of dental implants are part of the Axelmed® Dental Implant System, a clinical proven range of implantolgy products, and may be used only with the Axelmed® original components and instruments. The use of non original products, made by third parties, such as implant clones, abutments, screws, drills, instruments, components, etc. in conjunction with the Axelmed® Dental Implants System will void any warranty.

The user of Axelmed® products is the only responsible for determining whether or not any product is suitable for a patient. Axelmed® disclaims any liability and bears no responsibility for any direct/indirect damages, coming from or in connection with any practice errors in the use of Axelmed® products. The user is obliged to study the applications of Axelmed® products regularly.

The descriptions and explanations contained in this document are not sufficient for the proper use of the Axelmed® Dental Implant System. Professional knowledge of dental surgery, implantology and training in the handling of the Axelmed® Dental Implant System provided by a licensed and experienced operator, are always necessary. For detailed instructions please contact the local Axelmed® distributor/representative.

Amendments, errors and misprints may occur, as products are under continuous development. All items, product illustrations, texts, technical data, features, general contents, prices, etc. are intended only as examples and may vary without prior notice.

®Axelmed and ®Paradigma are registered marks of the AXELMED Company. *All the above mentioned names related to Companies and/or Products and/or Brands are only used foridentification purposes. All the trademarks belong to their respective owners.

The publication of the present catalogue supersedes and invalidates the previous versions.

©2016 AXELMED Company – All rights reserved. Reproductions, translations, storage and electronic processing are not permitted without prior written permission from AXELMED Company.

AXELMED S.R.L. Via della Liberazione, 5820098 S. Giuliano, Milan | Italy

0068

37

Main Features

Paradigma® Implant 04SAP surface 08Primary stability report 10Clinical Cases 12Axelmed® Abutments 16BRD Drills and Packaging 18ALL-in-ONE KIT 20

Catalogue

ALL-in-ONE 22Single Implants 23Healing Caps 24Impression Components 25Temporary Abutments 26Definitive Abutments 27Multi-Unit Components 28Ball Abutments 29Surgery Kit 30Surgery Drills 31Surgery Instruments 32Reference Table 34General Informations 36Disclaimers 37

Index

38

life from titanium

Axelmed Clinical Center

In our dental clinic in Milan, we test all our products directly and we research for new solutions to improve safety, features, ergonomics, aesthetics. All our implant line devices are studied, developed and accurately tested in real clinical cases before production and release on market.

We put great care in the study of every single detail of our implant system and we test each compo-nent every day to avoid the smallest complication to our fellow dentists. The Axelmed Dental Clinic is also used as a training centre for our distributors’ specialists and clinicians.

In our dental laboratory, we have developed and tested all the prosthetic products of the Axelmed Implant System. We take care of all the different aspects relevant to aesthetics and functionality of functional prosthetic restorations following the entire rehabilitation process, from the impression to the cementation.

In our internal cad-cam division, we use CAD design digital stations and CAM-CNC milling systems and modern materials as zirconia, new bers and composites, etc. in association with the Axelmed Abutments and prosthetic products.

Axelmed Dental Clinic

Axelmed Dental Laboratory

39

paradigma

Ver.

EN

2.0

• 4

/2018

AXELMED S.R.L. Via della Liberazione, 5820098 S. Giuliano, Milan | Italy

eMail: [email protected]: www.axelmed.com

Phone +39 02 9828 2694 Fax +39 02 9828 5327

®

EN

Documents

EN paradigma - axelmed.com · Microstructured High Purity Surface (SAP) 2 Sandblasted small grit Acid etched triple attack Plasma Double treatment to reduce healing time.(2) Flat