TOUAREG CloseFit™ UNP 2.75mmD

K153111 · Adin Dental Implants Systems , Ltd. · DZE · May 6, 2016 · Dental

Device Facts

• Record ID: K153111
• Device Name: TOUAREG CloseFit™ UNP 2.75mmD
• Applicant: Adin Dental Implants Systems , Ltd.
• Product Code: DZE · Dental
• Decision Date: May 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate. The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

Device Story

TOUAREG CloseFit™ UNP 2.75mmD is a two-piece endosseous dental implant system; features tapered core, spiral tap, and triple lead thread design. Used by dental professionals in clinical settings for tooth replacement. Implant is surgically placed into mandible or maxilla; used with cover screws, healing abutments, and abutments. Provides a conical-hex connection. Benefits include restoration of masticatory function. Clinicians use the device to support crowns, bridges, or overdentures. Output is the physical implant structure serving as an artificial root.

Clinical Evidence

No clinical performance data is provided in this submission. Bench testing only (fatigue testing per ISO 14801:2007).

Technological Characteristics

Material: Ti6Al4V ELI (ASTM F 136-08). Design: Tapered core, spiral tap, triple lead thread (3x1mm). Connection: Conical-hex. Surface: OsseoFix™ and anodized. Dimensions: 2.75mm diameter; 10, 11, 13, 16, 18mm lengths. Sterilization: Sterile.

Indications for Use

Indicated for patients requiring replacement of missing teeth in mandible or maxilla. Specifically for maxillary lateral incisors and mandibular lateral and central incisors. Suitable for single or multiple unit applications, single or two-stage procedures, and immediate or delayed loading if primary stability is achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Adin Dental Implant Systems Ltd. Touareg CloseFit™ NP (K140293)

Reference Devices

• Anthogyr SAS Axiom 2.8 implant (K141450)
• Adin Dental Implant Systems Ltd. Touareg CloseFit™ (K112585)

Submission Summary (Full Text)

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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 stylized eagle or bird symbol, with three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

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

May 6, 2016

Adin Dental Implants Systems Ltd. c/o Iman Khorshid CEO, Founder ORS Industrial Park Tefen Tefen 2495900 ISRAEL

Re: K153111

Trade/Device Name: TOUAREG CloseFit™ UNP 2.75mmD Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 31, 2016 Received: April 6, 2016

Dear Iman 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. 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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Tina Kiang
-s

for 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

Enclosure

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# Indications for Use

510(k) Number (if known)

K153111

Device Name TOUAREG CloseFit™ UNP 2.75mmD

#### Indications for Use (Describe)

TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 an one-stage surgical is applied, the implant maybe immediately loaded when good primary stability is achieved and thefunctional load is appropriate.

The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.

# 510(k) Summary:

## TOUAREG CloseFit™ UNP 2.75mmD Implants

Company Name: Adin Dental Implants Systems Ltd. Alon Tavor Industrial Zone P.O.Box 1128, Afula Hazafon, 1811101 ISRAEL Telephone: + 972-4-6426732 Fax: +972-4- -6426733

#### Establishment Registration Number: 3007518363

| Contact Name: | Iman Khorshid – Regulatory Consultant<br>QRS |
|---------------|----------------------------------------------|
| | Mobile: [phone] |
| | Telephone: + 972-4-6860006 |
| | Fax: [phone] |
| | E-mail: [e-mail] |

US Agent: Markus Weitz Adin Implants USA 657 Central Ave Cedarhurst , NY 11516 Phone: [phone] 7642349 Fax: E-mail: [e-mail]

Date prepared: May 5, 2016

Trade Name: TOUAREG CloseFit™ UNP 2.75mmD

Classification name: Endosseous Dental Implant

Common/usual name: Dental Implant

Product Code: DZE; NHA

Regulation No.: 872.3640

Class: II

Panel identification: Dental Devices Panel

510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 1 of 5

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Image /page/4/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a blue circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.

# Predicate Devices:

Primary Predicate: Adin Dental Implant Systems Ltd. dental implants Touareg CloseFit™ NP, cleared under 510(k) K140293.

Reference Predicates: Anthogyr SAS' Axiom 2.8 implant cleared under 510(k) K141450 and Adin Dental Implant Systems Ltd. dental implants Touareg CloseFit™, cleared under 510(k) K112585.

# Description of the device:

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system is comprised of a tapered core implant with a spiral tap, with unique tip and triple lead thread design (3x1mm).

The TOUAREG CloseFit™ UNP 2.75mmD spiral implant system offers a unique, strong and solid conical-hex connection.

All Touareg CloseFit™ implants feature the OsseoFix™ surface treatment The TOUAREG CloseFit™ UNP 2.75mmD implant is provided with a diameter of 2.75mm and lengths of 10, 11, 13, 16 and 18 mm.

The TOUAREG CloseFit™ UNP 2.75mmD implants are two piece devices whereas the implant is to be used in combination with cover screws, healing abutments and abutments.

The TOUAREG CloseFit™ UNP 2.75mmD implants, abutments, and abutment fixation screw are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 2 of 5

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Image /page/5/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 on the left, followed by the word "ADIN" in large, bold, dark blue letters. Below the word "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller font size. There is also a curved line above the word "ADIN".

## Indications for Use:

TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 thefunctional load is appropriate.

The TOUAREG CloseFit™ UNP 2.75mmDDental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.

### Substantial Equivalence:

### Technological Characteristics

The TOUAREG CloseFit™ UNP 2.75mmD implants have the same intended use as Adin Dental Implant Systems Ltd. TOUAREG NP CloseFit™ Dental Implants, cleared under 510(k) K140293 with the exception of the elimination of the specific indications for the TMA Abutment cleared in the primary predicate K140293 but is not included in the current submission device. Further the indications for the submission device are identical to the reference predicate K141450. The material used for the TOUAREG CloseFit™ UNP 2.75mmD dental implants and abutment (Ti6AL4V ELI), as well as the surface treatment and other manufacturing methods, are identical to Adin's TOUAREG NP CloseFit™ Dental Implants as well as previously cleared Adin's TOUAREG CloseFit™ Dental Implants, cleared under 510(k) K112585. The sterility status of the implant bodies and abutments are identical to Adin's previously cleared TOUAREG NP CloseFit Dental Implants and the previous sterilization validation supports the sterility of the current submission. The available abutment designs are similar to the applicant's own previously cleared dental abutments and the maximum angulation of the abutment is the same as the applicant's own predicate devices as well as supported for substantial equivalence by fatigue test results.

The main differences between the submission device and the primary predicate 510 (k) TOUAREG CloseFit™ UNP 2.75mmD Implants Section E - Page 3 of 5

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Image /page/6/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle, followed by the text "ADIN" in a bold, sans-serif font. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller, sans-serif font.

are the reduction in implant body diameter for the submission device from 3.0mm to 2.75mm and the inclusion of an 18mm length implant body. The reference predicate Axiom 2.8 Implant K141450 supports the reduction in implant body diameter. The reference predicate K112585 supports the inclusion of a longer implant body.

| | Touareg CloseFitTM<br>UNP Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd. | Touareg NP<br>CloseFitTM Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd. | Axiom® 2.8<br>Implants from<br>Anthogyr SAS | Touareg CloseFitTM<br>Dental Implants<br>from Adin Dental<br>Implant Systems<br>Ltd. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Predicate | | Primary Predicate | Reference Predicate | Reference Predicate |
| 510(k)<br>number | | K140293 | K141450 | K112585 |
| Product<br>Code | DZE | DZE | DZE | DZE |
| Indications<br>For Use | TOUAREG<br>CloseFitTM UNP<br>2.75mmD implants | Intended use for<br>Touareg NP<br>CloseFitTM Dental | ANTHOGYR<br>Axiom® implants<br>are intended for use | Touareg CloseFitTM<br>Dental Implants are<br>intended for |
| Touareg CloseFit™<br>UNP Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd. | Touareg NP<br>CloseFit™ Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd. | Axiom® 2.8<br>Implants from<br>Anthogyr SAS | Touareg CloseFit™<br>Dental Implants<br>from Adin Dental<br>Implant Systems<br>Ltd. | |
| are indicated to<br>replace missing<br>masticatory<br>functional units<br>(teeth) in single or<br>multiple unit<br>applications within<br>the mandible or<br>maxilla. For single-<br>stage or two-stage<br>procedures. For<br>immediate<br>implantation in<br>extraction sites or<br>implantation in<br>partially healed or<br>completely healed<br>alveolar ridge<br>situations. When an<br>one-stage surgical<br>approach is applied,<br>the implant maybe<br>immediately loaded<br>when good primary<br>stability is achieved<br>and the functional<br>load is appropriate.<br>The TOUAREG<br>CloseFit™ UNP<br>2.75mmDDental<br>Implant shall only<br>be used to replace<br>maxillary lateral<br>incisors and<br>mandibular lateral<br>and central incisors. | Implant System:<br>_ To replace<br>missing masticatory<br>functional units<br>(teeth) in single or<br>multiple unit<br>applications within<br>the mandible or<br>maxilla.<br>_ For single-stage<br>or two-stage<br>procedures.<br>_ For immediate<br>implantation in<br>extraction sites or<br>implantation in<br>partially healed or<br>completely healed<br>alveolar ridge<br>situations. When a<br>one-stage surgical<br>approach is applied,<br>the implant may be<br>immediately loaded<br>when good primary<br>stability is achieved<br>and the functional<br>load is appropriate.<br>The Touareg NP<br>CloseFit™ Dental<br>Implant shall only<br>be used to replace<br>maxillary lateral<br>incisors and<br>mandibular lateral<br>and central incisors.<br>_ The Trans<br>Mucosal Abutment<br>(TMA) is indicated<br>for multiple-unit,<br>screw-retained | as artificial<br>root structures for<br>replacement of<br>missing teeth. They<br>can be<br>used for fixation of<br>single tooth<br>restorations.<br>ANTHOGYR<br>dental systems are<br>indicated for one-<br>stage or two stage<br>surgery. It is up to<br>the practitioner to<br>decide whether<br>immediate or<br>delayed loading is<br>most appropriate,<br>based on<br>clinical factors like<br>good primary<br>stability and<br>appropriate<br>occlusal loading.<br>Axiom® 2.8<br>implants are<br>indicated for single<br>replacement of<br>mandibular incisors<br>and lateral<br>maxillary incisors<br>in cases<br>presenting a<br>restricted<br>mesiodistal space.<br>The prosthetic<br>components of the<br>Axiom 2.8 product<br>line are<br>intended to ensure<br>support for single | surgical placement<br>in the maxillary<br>and/or mandibular<br>arch to support<br>crowns, bridges, or<br>overdentures in<br>edentulous or<br>partially edentulous<br>patients.<br>Touareg CloseFit™<br>Dental Implants<br>may be immediately<br>loaded when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | |
| | Touareg CloseFitTM<br>UNP Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd. | Touareg NP<br>CloseFitTM Dental<br>Implants from Adin<br>Dental Implant<br>Systems Ltd.<br><br>restorations, and<br>may be used in<br>combination with<br>an implant level<br>framework design. | Axiom® 2.8<br>Implants from<br>Anthogyr SAS<br><br>crowns only. | Touareg CloseFitTM<br>Dental Implants<br>from Adin Dental<br>Implant Systems<br>Ltd. |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes |
| Re-use | No | No | No | No |
| Material of<br>Construction | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Surface<br>Treatment | OsseoFixTM and<br>anodized | OsseoFixTM and<br>anodized | BCP® | OsseoFixTM and<br>anodized |
| Length | 10, 11.5, 13, 16 and<br>18 mm | 10, 11.5, 13 and 16<br>mm | 10, 12, and 14 mm | 8, 10, 11.5, 13, 15<br>and 18 mm |
| Thread<br>Diameter | 2.75 mm | 3.0 mm | 2.8 mm | 3.5, 4.3 and 5.0 mm |
| Abutment | Straight and up to 15° | Straight and up to 15° | Straight and up to 23° | Straight and up to 15° |
| Material of<br>Construction<br>of<br>Abutments | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI | Titanium Alloy –<br>Ti6Al4V ELI |

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Image /page/7/Picture/0 description: The image is a logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle on the left side of the logo. To the right of the circle is the company name, "ADIN", in large, bold, blue letters, with the words "DENTAL IMPLANT SYSTEMS LTD" in smaller letters underneath.

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Image /page/8/Picture/0 description: The image is the logo for ADIN Dental Implant Systems LTD. The logo features a stylized letter "A" inside of a circle on the left, followed by the text "ADIN" in bold, dark blue letters. Below the text "ADIN" is the text "DENTAL IMPLANT SYSTEMS LTD" in a smaller font size.

# Non-Clinical Performance Data

Fatigue test was performed according to ISO 14801:2007 on the TOUAREG

CloseFit™ UNP 2.75mmD dental implants and showed equivalence to the predicate devices.

Clinical Performance Data

No clinical performance data is provided in this submission.

## Conclusion:

The evaluation of the TOUAREG CloseFit™ UNP 2.75mmD dental implants may therefore be considered substantially equivalent to its predicate device.