Ards Implants Catalog

ISO 0483

13485

Company’s profile ARDS was established by Dr. Uri Arny and deals with the development, manufacturing and marketing of dental implants. ARDS’s guiding philosophy has inspired the company to develop a unique drilling technique which causes minimum damage to the bone and maximizes the initial stabilization of the implants in it. Dr. Arny Uri, ECO

ARDS retains a number of international patents regardingA. 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 ways1. 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 packing supervised processes are done at the production plant situated at the industrial park of Teffen, Israel.

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ARDS also markets super structures and bone substitutes, thus expanding the variety of solutions dentists can offer their patients.

External Surface

The required durable stabilization of the implant in the bone needs oseointegration. In order to intensify the osseointegration two processes are required: The first is blasting the implant surface with small parts of silica which is not attached 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 Titanium

ARDS implants are composed of medical titanium alloy Ti-6 AL-4V which retains all the manufacturers’ regulations.

Manufacturing

All ARDS implants and reconstruction parts are manufactured 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 technical laboratories and NAMSA laboratory, U.S.A. Testing results - ARDS Implants

Corrosion

Biocompetabily

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.

The test was performed by NAMSA laboratory in the United States There 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: Complete stability of the ARDS Implant - The implants are stable and has no corrosion potential.

Results: All three tests proved that the implant is biocompetabily

Testing of the surface area

Testing fatigue

The test was performed by the Technion, Haifa - Test no. B/83703 The test was performed by an electronic microscope (SEM), that is equipped with a system analysis of chemical elements (EDS). The test was performed by injecting a wet metallic acid on the surface aera of the implant, and final cleaning by an organic acid.

The test was performed by the Technion, Haifa - Test no. B/83371 The test was performed on 3.75mm implants, 13mm in length. The implants were assembled with angulated abutments of 25 degrees. The implants were exposed to cyclic forces up to a fraction of one part. Testing done in accordance with standards of ISO 14801 and the FDA regulations.

Results: No absorption of foreign materials on the surface area, and the observed elements stands up to the highest standards.

Results: The only cracks were in the abutment screw to the level of 580 neuton, much more than required. In the assembly and the implant there was NO damage at all.

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Hybrid Dual Thread Screw Implant Analytical and Experimental Research Dr. Uri Arny, Ilan Weissberg M.Fc & Oved Gihon, Mechanical engineer. Introduction

As the popularity of using implants in dental restorative procedure gains momentum, there is a need to find innovative dental implant, which will effectively transfer the loads and provide a necessary stabilization into jawbone. 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 reinforcement of the implant in the jawbone by a reduction of the drilling bone volume along with an additional gain of primary surface contact relatively to classical implants. To prove the concept, analytical models and experiment tests were carried out during the development of an implant with Hybrid Dual Thread Screw (HDTS). The analytical calculations are based on Finite Element Model, while the experiment tests were done on an artificial bone made of Fiberglass and Structural foam, which represents 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.

Experimental Method

Force-displacement tests have been carried out on Classical 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 calculated.

Implant Artificial Cancellous

Artificial Cortical

Fig. 2: Artificial Bone Specimen

HDTS Implant Description

The 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 interface for favorable load distribution. Also it reduces the amount of bone removed by using a novel drilling procedure. Double Tread Thin Grove

Single Tread Thick Grove

Fig. 3: Artificial Bone Specimen Cross Section (Dimensions in mm>)

Figure 1: Hybrid Dual Thread Screw (HDTS) Implant

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Experimental Results

The experimental tests showed that the HDTS implant could carry higher axial load compared to classical cylinder implants, as is shown in figure 4. It is also shown that HDTS implant has higher stiffness then the classical cylindrical 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 Method

Finite 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 distribution 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.

shear stress distribution in the cortical bone under an axial load of 40 Kg for the both type of implants.

Discussion & Conclusions

The 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 specimen. These experiments were done with a background of analytical calculations. The lower shear stress values at the cortical bone evaluate for the HDTS implant compared to with the classical cylindrical implants provides the advantage of the HDTS implant regarding on carrying higher loads and increasing life time of the HDTS implant. This phenomenon is mostly due to the innovative implant geometry and bone drilling method.

Analytical Results

The analytical calculations showed that the HDTS implant have favorable stress distribution over the classical 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. 6: The Max Cortical Shear Stress Distribution for the Two Implants Models @ 40 Kg Vertical Load

References

Fig. 4: Implant tests under compression axial load

Lawrence B. Lum,A Biomechanical Rationale for the use of Short Implants. Journal of Oral Implantology Vol. XVII/ No. Tow/1991 pp126-131 Borchers L. Relchart P. “Three- dimensional stress distribution around a dental implant at different stages of interface development”. J. Dent Res 1983 62(2):156-159 Kitoh, M; Matsushita, Y.; Yamautue, S; Ikedda, H.; and Suetsugu, T. The Stress Distribution of Hydroxyapatite Implant Under Vertical Load by the Two-Dimensional Finite Element Method. Journal of Implantol 14:65-71 Dechow P.C. Naill G.A. Schwartz-Dabney C.L. and Ashman R.B., “Elastic properties of the human supraorbital and mandibular bone”. Am J Phys Anthropol 90, pp 291306. 1993.

Fig. 5: Analytical Model for HDTS Implant

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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.

3mm

3.75mm

4.2mm

4.5mm

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Implants Length

3mm

Code

Length

Code

10mm

N31000

10mm

N31017

11.5mm

N31100

11.5mm

N31117

13mm

N31300

13mm

N31317

3mm

Length

Code

10mm

S37510

11.5mm

S37511

13mm

S37513

3.75mm

Length

Code

10mm

S42010

11.5mm

S42011

13mm

S42013

4.2mm

Length

Code

10mm

S45010

11.5mm

S45011

13mm

S45013

4.5mm

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Healing screw Surgical screw of titanium alloy to cover all ARDS implants, 3.75, 4.2, 4.5 comes with every implant.

Code

S45013

Leading Pins Leading pin of titanium alloy Marked 3mm from tip, both sides comes with the implant disposable.

Length

16mm

14.5mm

Code

13mm

LD0016

11.5mm

LD0014

10mm

LD0013

13mm

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Drills Code DR0010 Marking

Code DR0020

Marking

2mm

Marking

13mm

10mm

5.5mm

Code DR0028

2mm

2.8mm

3mm

Marking

13mm

10mm

5.5mm

Code 2mm

DR0036

2.8mm

3.6mm

3.75mm

Marking

13mm

10mm

5.5mm

Code 2mm

2.8mm

DR0040

3.6mm

4mm

4.2mm

13mm

10mm

5.5mm

Code Marking

2mm

2.8mm

3.6mm

DR0042

4mm

4.2mm

4.5mm

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Prosthetic Components Healing Caps

Code

HO3000 Healing cap for 3mm ARDS implants

Code

Healing cap - straight hight: 3mm

HO3753

Code

Healing cap - straight hight: 5mm

HO3755

Code

Healing cap – wide hight: 3mm

HW3753

Code

Healing cap – wide hight: 5mm

HW3755

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Prosthetic Components Abutments Code

Straight abutment hight: 0mm

A37500

Code

Straight abutment hight: 3mm

Code Straight abutment Wide hight: 0mm

A3750W

A37530

Code Straight abutment Wide hight: 3mm

A3753W

Code A30000 Abutment for 3mm ARDS implants

Code A37515 15deg. Abutment

Code A37525 25deg. Abutment

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Prosthetic Components Shoulder Abutments Abutment made of titanium alloy antirotational Available in 4 heights of neck: 1mm, 2mm ,3mm ,4mm Fits 3.75, 4.2, 4.5 mm ARDS implants Indicated specially for one stage and immediate loading technique.

Code

Shoulder Abutment hight: 1mm

AS3751

Code

Shoulder Abutment hight: 2mm

AS3752

Code

Shoulder Abutment hight: 3mm

AS3753

Code

Shoulder Abutment hight: 4mm

AS3754

Code

Universal Plastic Sleeve with internal hex

AS375S

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Prosthetic Components Ball Attachment Components Ball attachment with 1mm, 2mm and 3mm neck for 3.75mm, 4.2mm and 4.5mm ARDS Implants

Code BA3751

Ball Attachment hight: 1mm

Code BA3752

Ball Attachment hight: 2mm

Code BA3753

Ball Attachment hight: 3mm

Code BA3000 Ball attachment for 3mm ARDS Implants

Code

Code

SILATC Silicon Cap

TITHOL Metal Cap

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Prosthetic Components Overdenture Components

Code

1mm overdenture intermediate component that connect between The implant and the plastic sleeve.

OD3751

Code

2mm overdenture intermediate component that connect between The implant and the plastic sleeve.

OD3752

Code

3mm overdenture intermediate component that connect between The implant and the plastic sleeve.

OD3753

Code

Plastic casting sleeve without internal hex for overdenture Intermediate components.

ODS002

Code ODS001 Screw for overdenture intermediate part.

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Prosthetic Components Accessories

Code AN3000 Laboratory analog for 3mm ARDS implants.

Laboratory analog to be used along with transfer, fits 3.75mm, 4.2mm, 4.5mm implant diameters.

Code AN3750

Laboratory analog to be used for overdenture, fits 3.75mm, 4.2mm, 4.5mm implant diameters.

Code AOD375

Code TR3750

Transfer for impression to be used along with 3.75mm, 4.2mm, 4.5mm ARDS implants.

Code

Plastic Sleeve Multi

P3750M

Code

Plastic Sleeve Single

Code

Plastic Sleeve Wide/Single

P3750W

P3750S

Code Plastic Sleeve for 3mm ARDS Implants

OD3000

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Tools

Code BOX001 Surgical box

Code MT0008 Ratchet for ARDS implants

Length

Code

15mm

MT0002

7mm

MT0001

Ratchet Driver for ARDS implants

Length

Code

15mm

MT0004

7mm

MT0003

Hand Driver for ARDS abutments and screws

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Length

Code

15mm

MT0006

7mm

MT0005

Ratchet Driver for ARDS abutments and screws

Code MT0007 Ratchet Driver for ARDS overdentures

Code MT0009 Implant Driver for hand piece

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Bone Substitutes and Membranes

Collagenated fillers composition

Gen-Os

Mix of cancellous and cortical heterologous bone with collagen. Granulometry : 250 -1000µ (micron)

Apatos

Heterologous cortical and cancellous bone without collagen. Granulometry - 600 - 1000µ (micron)

MP3

Gel 40

Special

Evolution

Heterologous cortico-cancellous collagenated bone mix with 10% collagen gel type 1 and 3. Granulometry - 600 - 1000µ (micron)

Translucent dried membrane,heterologous pericardium. Packeging : 20x20, Xfine

Collagen gel loaded with 60% bone mix of cancellous and cortical heterologous bone. Granulometry ≥ 300µ (micron)

Dried heterologous pericardium membrane. Packaging : 20x20, 25x35 Standard or fine

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Regeneration Type

Product 1

Product 2

Possible Alternatives

Post - Extractive Sockets

Only if Defect Walls Are Preserved

Only if there is Graft Exposure Risk

In case of Coagulation Problems

Crestal Access Sinus Lift

Gel with granules ≤ 300 Micron

Lateral Access Sinus Lift

Granulometry 600 - 1000

Antrostomy Covering

Granulometry 250 - 1000

Two Wall Defects

Granulometry 250 - 1000

Standard Model

Must be fixed with Osteosynthesis Screws

Intrabony Defects

Small Defects with < 30˚ Angle

Deep Defects and Furcations

Granulometry 250 - 1000

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Prosthetic Options Fixed Removable Overdenture

Healing Caps

Intermediate Parts

Casting Sleeves

Customized Tray in place

Final Casted Bar

Final Restoration

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Prosthetic Options Removable Overdenture

Healing Caps

Intermediate Parts

Casting Sleeves

Customized Tray in place

Final Casted Bar with ball attachments

Final Restoration

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Prosthetic Options Cemented Related Restorations

Straight Abutment

15˚ Abutment

25˚ Abutment

Shoulder Abutment

Prosthetic Options Fixed Removable Restorations

Plastic Sleeve for single restoration

Plastic Sleeve for Multiple restoration

Wide Plastic Sleeve

Plastic Sleeve with intermediate part

Plastic Sleeve for 3mm implant

Abutment for 3mm implant

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Designed by: Netto Solutions ©

www.ardsimplants.com

4 Hashikma st. Rishon Le-Zion, Israel. 75201 Tel. 972-3-9643320 Mail: [email protected]

ISO 13485