T.B.R. ZIRCONNECT

K070935 · Sudimplant SA · DZE · Nov 9, 2007 · Dental

Device Facts

• Record ID: K070935
• Device Name: T.B.R. ZIRCONNECT
• Applicant: Sudimplant SA
• Product Code: DZE · Dental
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.

Device Story

T.B.R.® Zirconnect is a root-form, screw-type dental implant system; manufactured from Ti-6Al-4V alloy; features roughened surface (sandblasted/acid-etched) to promote osseointegration. System includes implants, restorative components (abutments), and surgical/laboratory accessories. Used by dental professionals in clinical settings for surgical placement into jaw bone. Provides structural support for artificial teeth; restores patient chewing function. Substantially equivalent to predicate systems based on similar design, materials, and intended use.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and effectiveness demonstrated via adherence to FDA guidance 'Class II Special controls guidance document: Root-form endosseous dental implants and endosseous dental abutments'.

Technological Characteristics

Material: Ti-6Al-4V. Design: Self-tapping threaded screw, tapered shape. Connection: Internal octagon. Surface: Sandblasted/acid-etched. Sterilization: Gamma radiation. Dimensions: Lengths 8-15.5mm, Diameters 3.5-5mm.

Indications for Use

Indicated for patients requiring surgical placement of endosseous dental implants in the upper or lower jaw to support prosthetic devices and restore chewing function.

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

• 3i Osseotite Certain NT (K031475)
• T.B.R.® ide@ conic (K050956)

Submission Summary (Full Text)

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# 510(k) Summary

K070935

NOV () 9 2007

Sudimplant, SA Submitter: Parc de la Plaine 24, impasse René Couzinet 31500 Toulouse, FRANCE Tel: [phone] Fax: [phone]

#### Contact: Mr. Didier Sailhan Regulatory Affairs Manager E-mail: [e-mail]

Date: March 28, 2007

Device Name: T.B.R.® Zirconnect

Classification Name: Endosseous dental implant (21 CFR 872.3640) and Endosseous dental implant abutment (21 CFR 872.3630)

#### Class II Device classification:

# Legally marketed device (predicate devices):

- 3i Osseotite Certain NT (K031475) .
- T.B.R.® ide@ conic (K050956) ■

#### Description of the device:

The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.

#### Intended use:

The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.

### Performance:

This premarket notification was written in accordance with the FDA guidance "Class II Special controls guidance document:Root-form endosseous dental implants and endosseous dental abutments" issued on May 12, 2004. Test conclusions demonstrate the safety and effectiveness of T.B.R.® Zirconnect implant system.

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# Technological characteristics:

The overall design and characteristics of the T.B.R.® Zirconnect implants are similar to the predicated devices and as safe, as effective and as performs as well or better than the legally predicate devices.

| | T.B.R.<br>Zirconnect | T.B.R.<br>Ide@ Conic | 3i<br>Osseotite Certain<br>NT |
|----------------|--------------------------------|--------------------------------|--------------------------------|
| 510(k) number | | K050956 | K031475 |
| Type | Self-Tapping<br>Threaded Screw | Self-Tapping<br>Threaded Screw | Self-Tapping<br>Threaded Screw |
| Lengths (mm) | 8-10.5-13-15,5 | 8-10.5-13-15,5 | 8,5-15 |
| Diameters (mm) | 3.5-4-5 | 3.5-4-5 | 3,25-6 |
| Connection | Internal Octagon | Internal Octagon | Internal Hexagon |
| Shape | Tapered | Tapered | Tapered |
| Materials | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Surface | Sandblasted/ Acid-<br>etched | Sandblasted/ Acid-<br>etched | Acid-etched |
| Sterility | Gamma | Gamma | Gamma |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Mr. Didier Sailhan Regulatory Affairs Manager Sudimplant, SA Parc De La Plaine 24 Impasse Rene Couzinet 31500 Toulouse, FRANCE

Re: K070935

Trade/Device Name: T.B.R. @ Zirconnect Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 19, 2007 Received: October 22, 2007

Dear Mr. Sailhan;

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Sailhan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R. Gyl

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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):

Device Name: T.B.R.® Zirconnect

# Indications For Use:

The T.B.R.® Zirconnect endosseous dental implant is a device 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, and to restore the patient's chewing function.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

Sue Curry

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K070935