To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
For single-stage or two-stage procedures.
For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.

Device Description

Adin Touareg NP CloseFit™ dental implants are intended to be used as a replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.

Touareg NP (Narrow-Platform) CloseFit™ Dental Implants consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options.

Dental implants are surgically inserted into the upper and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).

AI/ML Overview

The provided text is a US FDA 510(k) premarket notification for a dental implant system. It describes the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. However, it does not contain a typical study report structure with specific acceptance criteria and detailed performance results that would be expected for a device proving its own acceptance criteria in the way a clinical trial or a performance study would.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary requirement for a 510(k) submission. This means the device is shown to be as safe and effective as a predicate device, rather than meeting novel acceptance criteria derived from a primary clinical study.

Therefore, many of the requested points (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set size, training set ground truth) are not directly applicable or available in this type of regulatory document. The "study" described here is a bench performance test (fatigue testing) used to compare the new device to its predicates.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

1. A table of acceptance criteria and the reported device performance

The document doesn't present a specific "acceptance criteria" table in the format typically seen for novel device performance claims. Instead, it states that the device was subjected to fatigue testing in accordance with FDA guidance and ISO 14801:2007. The acceptance criterion for this type of test is typically that the device must withstand a specified number of cycles at a certain load without failure, demonstrating performance equivalent to or better than the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Durability / Fatigue resistance (as per ISO 14801:2007)	"Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device. The testing represent that the implants and abutments are substantially equivalent to the identified predicates." (Page 9)
Sterility Assurance Level (SAL) of 10^-6 for radiation sterilization	"Sterilization is validated by the bioburden method. The sterility assurance level (SAL) that Adin Dental Implant Systems Ltd. intends to meet for the Touareg NP CloseFit™ Dental Implants is 10^-6." (Page 8) (Implied acceptance: SAL achieved)
Sterility Assurance Level (SAL) of 10^-6 for moist heat sterilization	"NP CloseFit™ Dental abutments also underwent extensive validation activities for moist heat sterilization for achieving a Sterility Assurance Level of 10^-6 (according to the FDA consensus standards) by using the parameters: Moist-Heat Sterilization at gravity fed autoclave 132 C° For 15 minutes exposure time, 20 minutes drying time, using the Overkill method. The sterlization was made in accordance with applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 17665-1:2006... and ISO 17665-2:2009..." (Page 9) (Implied acceptance: SAL achieved)
Cleaning, packaging, shelf-life validation	"NP CloseFit™ Dental Implant System also underwent extensive validation activities for cleaning, packaging, shelf-life and sterilization in accordance with Guidance... and all applicable recognized FDA consensus standards..." (Page 9) (Implied acceptance: validations successful)
Risk analysis conclusions	"Results of risk analysis, case studies, sterilization validation, and packaging testing have demonstrated that Touareg NP CloseFit™ Dental Implant System equivalent to the predicate device implants tested." (Page 9) (Implied acceptance: risks are comparable or acceptable)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "worst-case test samples" were identified and subjected to fatigue testing. It does not provide the specific number of samples (N) used for this testing.
Data Provenance: The tests are non-clinical, bench-top tests conducted to ISO standards. The company is Adin Dental Implant Systems Ltd. from Israel. The testing itself would likely have been done in a laboratory, potentially in Israel or by a certified testing facility elsewhere. This is not
retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the "test set" here refers to physical dental implant samples for bench testing, not a dataset requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for physical bench testing. The evaluation is based on objective measurements and observations of mechanical failure or integrity according to the ISO standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a physical medical device (dental implant), not a diagnostic AI device requiring human reader interaction or multi-reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the fatigue testing, the "ground truth" is the physical performance of the device samples against engineering and material science standards (e.g., ISO 14801:2007), where failure is an objective event. For sterilization, the "ground truth" is the demonstration of microbial lethality to achieve the specified Sterility Assurance Level.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31,2014

Adin Dental Implant Systems Limited Ms. Iman Khorshid VP Regulatory Affairs Industrial Zone Alon Tavor POB 1128 Afula Elit, 1811101 ISRAEL

Re: K140293

Trade/Device Name: Touareg NP CloseFit™ Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 16, 2014 Received: September 26, 2014

Dear Ms. Khorshid:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside a blue circle, followed by the text "ADIN" in bold, dark blue letters. Below the text, the words "ADIN DENTAL IMPLANT SYSTEMS LTD" are written in a smaller font.

Section 010- Indication For Use Statement

An Indication for Use Statement for the Touareg NP CloseFit™ Dental Implants System is provided below.

510(k) Number (if known): K140293

Device Name:

Touareg NP CloseFit™ Dental Implants System

Indications for Use:

Intended use for Touareg NP CloseFit™ Dental Implant System:

0 To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
For single-stage or two-stage procedures. O
For immediate implantation in extraction sites or implantation in 0 partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
. The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, ● screw-retained restorations, and may be used in combination with an implant level framework design.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Prescription Use
------------------	--

Over-The-Counter Use

(21 CFR 801 Subpart D)

AND/OR

(21 CFR 801 Subpart C)

OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Center for Devices and Radiological Health / CDRH

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Image /page/3/Picture/1 description: The image shows the logo for ADIN Dental Implant Systems LTD. The logo features a blue circular graphic on the left, followed by the text "ADIN" in bold, dark blue letters. Below "ADIN" is the text "ADIN DENTAL IMPLANT SYSTEMS LTD" in a smaller font size. A curved line extends over the logo.

Section 003- 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92 And according with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

Submitter Information

ADIN DENTAL IMPLANT SYSTEMS LTD Industrial Zone Alon Tavor POB 1128 Afula Elit, 1811101, Israel Tel: (+972)-4-9116162, Cell :( +972)-548-070-138, Fax: (+972) 4-6426733 iman@adin-implants.com Establishment Reg. Number: 3007518363

Submission contact person:

Iman Khorshid VP Regulatory Affairs Tel: (+972)-4-9116162, Cell :( +972)-548-070-138, Fax: (+972) 4-6426733 iman@adin-implants.com

Date of Submission: 21-

January-2014 Device

Classification

Trade/Proprietary Device Name:	Touareg NP CloseFit TM Dental Implant	Common
name:	Endosseous Dental Implant	21 CFR 872.3640
Product Code:	DZE (subsequent code NHA)
Classification Name:	Endosseous Dental Implant
Classification Regulation:	21 CFR §872.3640
Classification Panel:	Dental Devices
Regulatory Class:	II

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Image /page/4/Picture/1 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with a curved line extending from the top of the "A" to the right. The word "ADIN" is written in bold, dark blue letters to the right of the "A" symbol. Below "ADIN" is the text "Dental Implants Sys. LTD." in a smaller font size.

Identification of Primary Legally Marketed Predicate Devices

1. ADIN Dental Implant Systems, Endosseous Dental Implant cleared under K081751, (product code DZE, Regulation No. 872.3640).
1. Asstra Tech AB OsseoSpeed™ Narrow Endosseous Dental Implant cleared under K080396 (product code DZE, Regulation No. 872.3640).

Device Description and function

taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or a healing abutment is attached to the implant. The soft tissues are allowed to heal around

the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention. Touare TM-NP Dental Implants are available in diameter of 3.0mm with lengths of 8.10. 11.5, 13, and 16 mm. The implants and abutments are made from Ti-Al-V alloy which meets ASTM F-136 (Standard Specification for Wrought Titanium 6Al-4V ELI Allov for Surgical Implant Applications).

Flat connection abutments

Abutments with flat connection for screw retained restoration. Cement retained

abutments

These abutments are providing support to prosthetic restoration. The abutments are intended for cemented restorations. The abutment screw intends for securing the abutment to endosseous implant.

Healing Abutments

Healing abutments of specific diameters and shapes are fixated on the implants to displace the gingiva from the space above the implant during the Implant healing time and serve for proper gingiva shaping. They are available in diameters of 3.0 and 4.5mm.

Ball Attachment

Ball abutments are used for implant-retained mucosa-supported restorations, such as dentures.

The device is a prescription use, labeled "Rx only", the device is qualifies for exemption per 21 CFR 801 Subpart D.

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Image /page/5/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with the letters "DIN" in bold, dark blue font to the right of the "A". Below the letters "ADIN" is the text "Dental Implants Sys. LTD." in a smaller, lighter font. The logo has a professional and modern look.

The system includes accessories :laboratory analogs, impression copings, drivers for implants insertion (Class l exempt, not a subject of this submission) intended to facilitate the preparation of prosthetic restorations.

Additional description of specific items

The submission contains drawings of abutments compatible with 3.0mm diameter implant.

· The difference between the NP tapered cover screw (NP-0073) and the NP implant cover screw (NP-0002) is: NP-0002 is covering the outer diameter of the implant and NP-0073 is covering only the opening of the implant.
· The use of the NP Flat Connection Abutments (NP-0030 NP-0031) is: these are transmucosal abutments for retaining screw restoration.
· The use of the NP Locator Abutments 2-6mm (for example, NP-0052) is for "locator" attachment for Overdenture.
The use of the NP-Angled Trans Mucosal Abutments (NP-0035 NP-0038) is for: Correct angulations of dental implants, it is for the multi-unit, screw retained restorations. Used to elevate seating platform of restoration when restoration to implant level not practical.

Intended use for Touareg NP (Narrow-Platform) CloseFit™ Dental Implant system

The implants and the TMA abutments are intended to be used to:

. Replacement for missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
For single-stage or two-stage procedures.
For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations, when a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved, and the functional load is appropriate.
The Touareg NP CloseFit™ Dental Implant shall only be used to replace Maxillary lateral incisors and mandibular lateral and central incisors.
The Trans Mucosal Abutment System (TMA) is indicated for multiple-unit, screw-retained restorations, and ● may be used in combination with an implant level framework design.

Principle of Operation

Each Touareg NP CloseFit™ Dental Implant System has a unique design characteristic for matching implants. abutments and prosthetics once assembled.

When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate. The Touareg NP CloseFit™ Dental Implant system shall only be used to replace maxillary lateral incisors and mandibular Lateral and central incisors.

Performance Standards

The performance standards which were utilized for demonstrating potential equivalence in this submission were: ISO 14801, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737-1, ISO 11737-2, ISO 11138-1, ISO 11138-3, ISO 14644-1, ISO 14644-3, ISO 14644-4, ISO 14971,ISO 14161, ISO 10993-1, ASTM F136-12,ASTM F2338, AAMI ST79. AAMI TIR33. USP 71. USP 85. USP161. under Section 514 of the Federal Food. Drug, and Cosmetic Act.

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Image /page/6/Picture/0 description: The image is a logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" in blue, with a swoosh above the letters "ADIN". The text "Dental Implants Sys. LTD." is written in a smaller font below the letters "ADIN". The logo is simple and modern, and it is likely used to represent the company's brand.

Guidance

Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff

Comparison to the predicate device:

The Touareg NP CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System, K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg NP CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. In addition, its indications were extended (please see comparison table, in the Indication for use info).

Characteristic	Subject Dental Implant System	Predicate DentalImplant System	Predicate DentalImplant System
510(k)		K080396	K081751
Manufacturer	Adin Dental Implant Systems	ASTRA TECH AB	Adin DentalImplants System
Item	Touareg NP CloseFit™Dental Implant and abutments	OsseoSpeed™Narrow	Dental ImplantSystem
Indication foruse	•Replacement for missingmasticatory functional units(teeth) in single or multipleunit applications within themandible or maxilla.•For single-stage or two-stageprocedures.•For immediate implantation inextraction sites or implantationin partially healed or completelyhealed alveolar ridge situations,when a one-stage surgicalapproach is applied, the implantmaybe immediately	•To replace missingmasticatoryfunctional units(teeth) in single ormultiple unitapplications withinthe mandible ormaxilla.•The device may beused equally well in asingle stage ortwo-stage surgicalprocedure.•For immediateimplantation in	• Dental Implantsare intended forsurgical placementin the maxillaryand/or mandibulararch to supportcrowns, bridges, oroverdentures inedentulous orpartiallyedentulouspatients.• The DentalImplants may beimmediately
Characteristic	Subject Dental Implant System	Predicate Dental Implant System	Predicate Dental Implant System
	loaded when good primarystability is achieved, and thefunctional load is appropriate.The Touareg NP CloseFitTM Dental Implant shall only beused to replace Maxillary lateral incisors and mandibular lateraland central incisors. The Trans Mucosal Abutment System (TMA) is indicated formultiple-unit, screw-retained restorations, and may be used incombination with an implant level framework design.	extraction sites orimplantation inpartially healed orcompletely healedalveolar ridgesituations.When a one-stage surgical approach isapplied, the implant may be immediatelyloaded when good primary stability isachieved and the functional load isappropriate. The OsseoSpeed Narrow product lineshall be used only to replace maxillarylateral incisors and mandibular lateraland central incisors.	loaded when goodprimary stability isachieved and withappropriateocclusal loading
Performancespecification	The Implants were subjected tofatigue testing.	The Implants weresubjected to analysis ofmechanical strength.	The Implants weresubjected to analysisof mechanicalstrength.
Summary of thetechnologicalcharacteristics	The implants are Surgicallyimplanted in partially healed orcompletely healed alveolar ridgesituations When a one- stagesurgical approach is applied, theimplant may be immediatelyloaded when	Immediate loading ofsingle toothrestorations may not beappropriate in suchsituations.	The implants areSurgically insertedinto the upper and/orlower jawbone andare left to heal(osseointegrate)
Characteristic	Subject Dental Implant System	Predicate Dental Implant System	Predicate Dental Implant System
	good primary stability is achieved and the functional load is appropriate		with the bone for a period of up to six months
Angulations of dental system	17, 30	Not known	17
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI	Ti 6Al-4V ELI
Diameter	3.0mm	3.0mm
Manufacturing technology	Machining	Machining	Machining

Comparison Table for Dental Implant System:

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Image /page/7/Picture/0 description: The image is a logo for ADIN Dental Implants Sys. LTD. The logo features a blue circle with a white "A" inside of it. To the right of the circle is the word "ADIN" in large, bold, blue letters. Below the word "ADIN" is the phrase "Dental Implants Sys. LTD." in smaller, blue letters.

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Image /page/8/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter A inside of a blue circle. The company name is written in bold, blue letters to the right of the circle.

Packaging/Labeling/Product

Advertising material to be used for promotion of the Touareg NP CloseFit™ Dental Implants will be consistent with the indications for use and other materials shown herein.

All materials, suppliers, processing, packaging methods remain the same as those utilized for the predicate (K081751). Touareg NP CloseFit™ Dental Implants are packaged in a radiation sterilizable package. Sterilization is accomplished by means of Co 60 gamma irradiation.

Sterilization is validated by the bioburden method. The sterility assurance level (SAL) that Adin Dental Implant Systems Ltd. intends to meet for the Touareg NP CloseFit™ Dental Implants is 10 °. The device is not represented to be "pyrogen-free".

Abutments and instruments will be packaged non-sterile in plastic bags.

Safety & Effectiveness

The intended use of the submitted Toureg NP CloseFit™ Dental Implant System is identical to the legally marked devices Adin Dental Implants System - K081751

Similarity of intended use and technological features demonstrated, therefore, the risks and benefits are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of modified Touareg NP CloseFit™ Dental Implants.

Substantial Equivalence Statement:

Adin Dental Implant Systems Ltd. demonstrated that, for the purposes of FDA's regulation of medical devices, the Touareg NP CloseFit™ Dental Implant system is substantially equivalent in indications, design and functional features to predicate devices.

Brief Discussion and conclusions drawn from the Non-Clinical Tests Submitted

For a determination of substantial equivalence, the following analysis and bench performance test was performed on Subject Devices and Predicate Devices:

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Image /page/9/Picture/0 description: The image shows the logo for ADIN Dental Implants Sys. LTD. The logo features a stylized letter "A" inside a blue circle on the left. To the right of the circle, the word "ADIN" is written in large, bold, blue letters. Below the word "ADIN", the words "Dental Implants Sys. LTD." are written in smaller letters.

· Touareg NP CloseFit™ Dental Implant System was analyzed to identify worst-case test samples. These worst-case test samples (rational for choosing the Worst case is at Section 18) were subject to fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document" Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2007 "Dentistry-Implants-Dynamic fatigue test for Endosseous dental implants". The test was done with angled abutments to demonstrate the design changes did not change the fatigue properties. Fatigue testing also demonstrated that this system meets its predefined acceptance criteria and performs in accordance with its intended use. The fatigue properties of the new design are similar to those of the predicate device. The testing represent that the implants and abutments are substantially equivalent to the identified predicates.
· Further. NP CloseFit™ Dental Implant System also underwent extensive validation activities for cleaning. packaging, shelf-life and sterilization in accordance with Guidance for industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and all applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 11137-1, Sterilization of health care products -- Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. In addition, NP CloseFit™ Dental

abutments also underwent extensive validation activities for moist heat sterilization for achieving a

Sterility Assurance Level of 10 (according to the FDA consensus standards) by using the parameters: Moist-Heat Sterilization at gravity fed autoclave 132 C° For 15 minutes exposure time, 20 minutes drying time, using the Overkill method. The sterlization was made in accordance with applicable recognized FDA consensus standards for dental implants, including but not limited to ISO 17665-1:2006 Sterilization of health care products - Moist heat -- Part 1: Requirement, validation and routine control of a sterilization process for medical devices and ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.

· Results of risk analysis, case studies, sterilization validation, and packaging testing have demonstrated that Touareg NP CloseFit™ Dental Implant System equivalent to the predicate device implants tested.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.