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ISO13485
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Company’s profileARDS was established by Dr. Uri Arny and deals with thedevelopment, manufacturing and marketing of dentalimplants.ARDS’s guiding philosophy has inspired the company todevelop a unique drilling technique which causes minimum damage to the bone and maximizes the initial stabilization of the implants in it.
ARDS retains a number of international patents regarding-A. The shape of the implant’s surface.B. A drilling technique which preserves bone.C. Unique implants designed for thin ridges.
ARDS’s aspiration for perfection is conveyed in the following ways-1. Shortening the healing phase -immediate implant after extraction.2. The system enables the use of implants also in problematic areas.3. Making the implant process simple to assign. (User friendly).
The main advantages of ARDS drilling and implant process:1. Reduces the amount of drilled bone.2. Unique design of the implant increases the bone-implant contact in the surgery phase(in comparison with other implants of the same diameter) thus stabilizes the implant and shortens the process of bone- implant integration.3. ARDS’s drilling method and the shape of it’s implant causes a compression of the spongyosal bone around the apical part of the implant during its insertion. Dispersing the forces along the entire implant and not only at its upper part as in common implants held at the cortical bone at the end of the implantation.4. The drilling method enables precise control over the placement and shape of the bore hole. This is made possible by the usage of leading pins which direct the drill at the suitable angle throughout the process and stabilize it also in thin ridges.
ARDS’s main office and marketing management are situated at Rishon-Le-Zion, Israel. All manufacturing and packingsupervised processes are done at the production plantsituated at the industrial park of Teffen, Israel.
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Dr. Arny Uri, ECO
ARDS also markets super structures and bone substitutes, thus expanding the variety of solutions dentists can offer their patients.
External SurfaceThe required durable stabilization of the implant in the bone needs oseointegration. In order to intensify theosseointegration two processes are required:The first is blasting theimplant surface with small parts of silica which is notattached to the titanium surface so it leaves it pure.The second stage is etching the surface with organic acids which create the final micro pores of the surface and at the same time constitute the first cleaning stage of the surface area.
Type of TitaniumARDS implants are composed of medical titanium alloy Ti-6 AL-4V which retains all the manufacturers’ regulations.
ManufacturingAll ARDS implants and reconstruction parts aremanufactured at the company’s production plant, situated at the industrial park of Teffen in the north part of Israel. The plant contains quality control system and regulations of the highest required level with the approvals of ISO 9001, ISO 13485 of European body, CE 0483, and Israeli AMAR.
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Excellent approval for ARDS Implants from technicallaboratories and NAMSA laboratory, U.S.A.
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Testing results - ARDS Implants
Corrosion Biocompetabily
Testing of the surface area Testing fatigue
The test was performed by the Technion,Haifa - Test no. B/82454• The test examined the resistance of the material and its corrosion potential.• The test was performed by immersing the implant in diffrent chemicals, heating to 37˚ and submission to electrical currents.
Results:Complete stability of the ARDS Implant - Theimplants are stable and has no corrosionpotential.
The test was performed by NAMSAlaboratory in the United StatesThere were 3 tests done on laboratory mice• Toxicity test - toxic potential of the implant• Sensitivity test - sensitivity potential that could be caused by the implant• Irritation test - potential irritations of the implant.
Results:All three tests proved that the implantis biocompetabily
The test was performed by the Technion,Haifa - Test no. B/83703The test was performed by an electronicmicroscope (SEM), that is equipped with asystem analysis of chemical elements (EDS).The test was performed by injecting a wet metallicacid on the surface aera of the implant, and finalcleaning by an organic acid.
Results:No absorption of foreign materials on thesurface area, and the observed elementsstands up to the highest standards.
Results:The only cracks were in the abutment screwto the level of 580 neuton, much more thanrequired. In the assembly and the implantthere was NO damage at all.
The test was performed by the Technion,Haifa - Test no. B/83371The test was performed on 3.75mm implants, 13mm in length.The implants were assembled with angulatedabutments of 25 degrees.The implants were exposed to cyclic forces up to afraction of one part.Testing done in accordance with standardsof ISO 14801 and the FDA regulations.
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IntroductionAs the popularity of using implants in dental restorative procedure gains momentum, there is a need to find in-novative dental implant, which will effectively transfer the loads and provide a necessary stabilization into jaw-bone. This paper presents the development results of a novel implant with a Hybrid Dual Thread Screw as shown in Fig. 1. This approach allows obtaining a high reinforce-ment of the implant in the jawbone by a reduction of the drilling bone volume along with an additional gain of pri-mary surface contact relatively to classical implants.To prove the concept, analytical models and experiment tests were carried out during the development of an im-plant with Hybrid Dual Thread Screw (HDTS). The ana-lytical calculations are based on Finite Element Model, while the experiment tests were done on an artificial bone made of Fiberglass and Structural foam, which rep-resents the bone mechanical properties. These unique experimental tests have been chosen, since the clinical tests evaluations on animals are not efficient. The animal has different dental jaw structure and it requires a lot of time to get the results.
HDTS Implant DescriptionThe unique HDTS dental Implant, shown in Fig. 1, uses two different thread types, double thread thin grove at the implant interface area with the cortical bone and single thread thick groves at the cancellous. This unique design allows facilitating the transfer of occlusal forces to the greatest surface area of the bone-implant inter-face for favorable load distribution. Also it reduces the amount of bone removed by using a novel drilling pro-cedure.
Figure 1: Hybrid Dual Thread Screw (HDTS) Implant
Experimental MethodForce-displacement tests have been carried out on Clas-sical Cylindrical Implant and HDTS implant both have diameter of 4.5 mm and 13 mm in length. The implants have been inserted in an artificial bone specimen shown in Fig. 2, the cross section dimensions of this specimen are of a typical mandible as is shown in Fig. 3. An axial load was applied onto the implant head until failure was reached. During the static tests the force-displacement curves were recorded and axial stiffness has been calcu-lated.
Fig. 2: Artificial Bone Specimen
Fig. 3: Artificial Bone Specimen Cross Section (Dimensions in mm>)
Hybrid Dual Thread Screw Implant - Analytical and Experimental Research
Dr. Uri Arny, Ilan Weissberg M.Fc & Oved Gihon, Mechanical engineer.
Single TreadThick Grove
Double TreadThin Grove
ArtificialCortical
Implant
ArtificialCancellous
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Experimental ResultsThe experimental tests showed that the HDTS implant could carry higher axial load compared to classical cylin-der implants, as is shown in figure 4. It is also shown that HDTS implant has higher stiffness then the classical cylin-drical implant. The stiffness of the implants is compatible with measured axial stiffness of 180 Kg/mm published in the literature for Branemark (7 mm’) in trabecular bone. These results increase the reliability of the preformed experimental tests.
Analytical MethodFinite Element Model (FEM) of an implant installed in a standard jawbone cross section has been built using NASTRAN FEM software. The aim of this study was to evaluate the influence of HDTS implant versus classical cylindrical implants on the stress intensity and stress dis-tribution due to axial load. Two analytical models were built for the identical specimen types described above. The Implant stress distribution at the bone cross section was calculated.The FEM model of the dental implant bone system used 2-D Plate elements; the model is symmetrical since only axial (vertical) load was analyzed, as is shown in Fig. 5.
Analytical ResultsThe analytical calculations showed that the HDTS im-plant have favorable stress distribution over the clas-sical cylindrical implant. The maximal shear stress level at the cortical jawbone with HDTS implant is 15% to 25% lower compared with a classical cylindrical implant, this is shown in Fig 6, which plots the max
Fig. 4: Implant tests under compression axial load
Fig. 5: Analytical Model for HDTS Implant
shear stress distribution in the cortical bone under an axial load of 40 Kg for the both type of implants.
Discussion & ConclusionsThe experimental tests showed that HDTS implant achieved the highest vertical load capability compared with a classical cylindrical implant. The unique tests experiments method evaluates in this study provided short development time by using artificial bone speci-men. These experiments were done with a background of analytical calculations. The lower shear stress values at the cortical bone evaluate for the HDTS implant com-pared to with the classical cylindrical implants provides the advantage of the HDTS implant regarding on carry-ing higher loads and increasing life time of the HDTS im-plant. This phenomenon is mostly due to the innovative implant geometry and bone drilling method.
Fig. 6: The Max Cortical Shear Stress Distribution for the Two Implants Models @ 40 Kg Vertical Load
ReferencesLawrence B. Lum,A Biomechanical Rationale for the use of Short Implants. Journal of Oral Implantology Vol. XVII/No. Tow/1991 pp126-131Borchers L. Relchart P. “Three- dimensional stress dis-tribution around a dental implant at different stages of interface development”. J. Dent Res 1983 62(2):156-159Kitoh, M; Matsushita, Y.; Yamautue, S; Ikedda, H.; and Suetsugu, T. The Stress Distribution of Hydroxyapatite Implant Under Vertical Load by the Two-Dimensional Fi-nite Element Method. Journal of Implantol 14:65-71Dechow P.C. Naill G.A. Schwartz-Dabney C.L. and Ash-man R.B., “Elastic properties of the human supraorbital and mandibular bone”. Am J Phys Anthropol 90, pp 291-306. 1993.
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Packaging
Packaging contains:Implant, Healing cap, Leading pin, double-label to allow recording used implant on patient’s form.
All implants are sterilized and gamma-ray.
All implants are packed with mounling tool, no-touch delivery carrier.
All implants are double packed – the outer clean, the inner sterilized.
All super structure clean and ready to be used.
All implants comes with colour code improve their usability.
4.5mm4.2mm3.75mm3mm
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Implants
CodeLength
13mm
11.5mm
10mm
S37513
S37511
S37510
CodeLength
13mm
11.5mm
10mm
S42013
S42011
S42010
CodeLength
13mm
11.5mm
10mm
S45013
S45011
S45010
3mm
3.75mm
4.2mm
4.5mm
Length Code
13mm
11.5mm
10mm
N31300
N31100
N31000CodeLength
13mm
11.5mm
10mm
N31317
N31117
N31017
3mm
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Leading PinsLeading pin of titanium alloyMarked 3mm from tip, both sides comes with the implant disposable.
Code
S45013
CodeLength
10mm
11.5mm
13mm
LD0013
LD0014
LD0016
16mm 14.5mm 13mm
Healing screwSurgical screw of titanium alloy to cover all ARDS implants,3.75, 4.2, 4.5comes with every implant.
10
5.5
mm
13
mm
10m
m
5
.5m
m
13m
m
10m
m
5.5m
m
13m
m
10m
m
13m
m
10
mm
5.5
mm
DR0010
Code
DR0020
Code
DR0028
Code
DR0036
Code
DR0040
Code
DR0042
Code
Marking
2mm
2.8mm
3.6mm
4mm
4.2mm
Drills
Marking
Marking2mm
2mm2.8mm
Marking
2mm2.8mm
Marking
3.6mm
2mm2.8mm
Marking
3.6mm4mm
3mm
3.75mm
4.2mm
4.5mm
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Prosthetic Components Healing Caps
HO3000
Code
HO3753
Code
HO3755
Code
HW3753
Code
HW3755
Code
Healing cap – widehight: 3mm
Healing cap – widehight: 5mm
Healing cap for 3mm ARDS implants
Healing cap - straighthight: 3mm
Healing cap - straighthight: 5mm
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Prosthetic ComponentsAbutments
A37515
Code
A37525
Code
A37530
Code
A37500
Code
A3753W
Code
A3750W
Code
A30000
Code
Straight abutmenthight: 0mm
Straight abutmenthight: 3mm
Straight abutment -Widehight: 0mm
Straight abutment -Widehight: 3mm
Abutment for 3mm ARDS implants
15deg. Abutment
25deg. Abutment
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Prosthetic ComponentsShoulder AbutmentsAbutment made of titanium alloy antirotational Available in 4 heights of neck: 1mm, 2mm ,3mm ,4mm
Fits 3.75, 4.2, 4.5 mm ARDS implantsIndicated specially for one stage and immediate loading technique.
AS3751
Code
AS3752
Code
AS3753
Code
AS3754
Code
AS375S
Code
Shoulder Abutmenthight: 1mm
Shoulder Abutmenthight: 2mm
Shoulder Abutmenthight: 3mm
Shoulder Abutmenthight: 4mm
Universal Plastic Sleevewith internal hex
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Prosthetic Components Ball Attachment Components
BA3751
Code
BA3752
Code
BA3753
Code
BA3000
Code
TITHOL
Code
SILATC
Code
Ball attachment with 1mm, 2mm and 3mm neck for 3.75mm, 4.2mm and 4.5mm ARDS Implants
Ball attachment for 3mm ARDS Implants
Ball Attachmenthight: 1mm
Ball Attachmenthight: 2mm
Ball Attachmenthight: 3mm
Silicon Cap Metal Cap
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Prosthetic ComponentsOverdenture Components
OD3751
Code
OD3752
Code
OD3753
Code
ODS002
Code
ODS001
Code
1mm overdenture intermediate component that connect between The implant and the plastic sleeve.
2mm overdenture intermediate component that connect between The implant and the plastic sleeve.
3mm overdenture intermediate component that connect between The implant and the plastic sleeve.
Plastic casting sleeve without internal hex for overdentureIntermediate components.
Screw for overdenture intermediate part.
AN3000
Code
TR3750
Code
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Prosthetic ComponentsAccessories
AN3750
Code
AOD375
Code
P3750W
Code
OD3000
Code
P3750M
Code
P3750S
Code
Laboratory analog for 3mm ARDS implants.
Laboratory analog to be used for overdenture, fits 3.75mm, 4.2mm,4.5mm implantdiameters.
Laboratory analog to be used along with transfer, fits 3.75mm, 4.2mm, 4.5mm implant diameters.
Transfer for impression to be used along with 3.75mm, 4.2mm, 4.5mm ARDS implants.
Plastic SleeveMulti
Plastic SleeveSingle
Plastic SleeveWide/Single
Plastic Sleevefor 3mmARDS Implants
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BOX001
Code
Tools
Surgical box
CodeLength
7mm
15mm
MT0001
MT0002
MT0008
Code
CodeLength
7mm
15mm
MT0003
MT0004
Ratchet for ARDS implants
Ratchet Driver for ARDS implants
Hand Driver for ARDS abutments and screws
18
CodeLength
7mm
15mm
MT0005
MT0006
MT0009
Code
Ratchet Driver for ARDS abutments and screws
MT0007
Code
Ratchet Driver for ARDS overdentures
Implant Driver for hand piece
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Gen-OsMix of cancellous and cortical heterologous bone with collagen.Granulometry : 250 -1000µ (micron)
ApatosHeterologous cortical and cancellous bone without collagen.Granulometry - 600 - 1000µ (micron)
MP3Heterologous cortico-cancellous collagenated bone mix with 10% collagen gel type 1 and 3.Granulometry - 600 - 1000µ (micron)
Gel 40Collagen gel loaded with 60% bone mix of cancellous and corticalheterologous bone.Granulometry ≥ 300µ (micron)
SpecialTranslucent dried membrane,heterologous pericardium.Packeging : 20x20, Xfine
EvolutionDried heterologous pericardium membrane.Packaging : 20x20, 25x35Standard or fine
Bone Substitutes and Membranes
Collagenated fillers composition
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Post - Extractive Sockets Only if Defect WallsAre Preserved
Only if there isGraft Exposure Risk
In case of CoagulationProblems
Crestal Access Sinus Lift Gel with granules≤ 300 Micron
Granulometry250 - 1000
Lateral Access Sinus Lift Granulometry600 - 1000
Antrostomy Covering Granulometry250 - 1000
Two Wall Defects Granulometry250 - 1000
Standard Model Must be fixed withOsteosynthesis Screws
Intrabony Defects Small Defectswith < 30˚ Angle
Deep Defectsand Furcations
Regeneration Type Product 1 Product 2 Possible Alternatives
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Prosthetic OptionsFixed Removable Overdenture
Healing Caps Intermediate Parts
Casting Sleeves Customized Tray in place
Final RestorationFinal Casted Bar
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Prosthetic OptionsRemovable Overdenture
Healing Caps Intermediate Parts
Casting Sleeves Customized Tray in place
Final RestorationFinal Casted Bar with ball attachments
2@Im
2@Im
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Prosthetic OptionsFixed Removable Restorations
Prosthetic OptionsCemented Related Restorations
Straight Abutment 15˚ Abutment 25˚ Abutment Shoulder Abutment
Plastic Sleevefor single restoration
Plastic Sleevefor Multiple restoration
Wide Plastic Sleeve
Plastic Sleevefor 3mm implant
Plastic Sleevewith intermediate part
Abutmentfor 3mm implant
2@Im
٢@Im
٢@Im
ISO13485
www.ardsimplants.com4 Hashikma st. Rishon Le-Zion, Israel. 75201 Tel. 972-3-9643320 Mail: [email protected]
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