3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615

K033430 · Implant Innovations, Inc. · DZE · Nov 7, 2003 · Dental

Device Facts

• Record ID: K033430
• Device Name: 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The 3i TG OSSEOTITE® Wide Implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

Device Story

3i TG OSSEOTITE® Wide Implants are trans-gingival endosseous dental implants; feature internal morse-taper design; wider seating surface mimics natural tooth proportions in posterior jaw regions. Implants are surgically placed in upper or lower jaw by dental professionals to serve as anchors for prosthetic attachments. Device provides structural foundation for dental restorations; benefits patients by restoring function and aesthetics of missing teeth.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Trans-gingival endosseous dental implant; internal morse-taper connection; wide diameter design for posterior tooth replacement. Materials and manufacturing processes are consistent with predicate TG OSSEOTITE® line.

Indications for Use

Indicated for surgical placement in the upper or lower jaw of patients requiring prosthetic attachment.

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

• TG OSSEOTITE® Dental Implants (K972444)
• OSSEOTITE® IOL Implants (K031632)

Submission Summary (Full Text)

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16033430

## NOV - 7 2003 Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Tamara Nelson<br>International Regulatory Affairs Specialist<br>Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email [e-mail] |
| Date Prepared | October 24, 2003 |
| Device Name | <i>3i</i> TG OSSEOTITE® Wide Implants |
| Classification Name | Endosseous Dental Implant |
| Device<br>Classification | Class III<br>Dental Devices Panel<br>21 CFR § 872.3640 |
| Predicate<br>Devices | TG OSSEOTITE® Dental Implants<br>K972444<br>OSSEOTITE® IOL Implants<br>K031632 |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act. |
| Device Description | The <i>3i</i> TG OSSEOTITE® Wide Implants are trans-gingival<br>implants designed with an internal morse-taper. The wider<br>dimension of the seating surface provides a realistic size<br>proportion of a natural tooth of the posterior area. |
| Indications for<br>Use | The 3i TG OSSEOTITE® Wide Implants are<br>indicated for surgical placement in the upper or lower jaw<br>to provide a means for prosthetic attachment. |
| Technological<br>Characteristics | The 3i TG OSSEOTITE® Wide Implants contain features<br>and functions which are similar to the currently available<br>TG OSSEOTITE® Implants. |
| Conclusion | The 3i TG OSSEOTITE® Wide Implants are substantially<br>equivalent to the legally marketed TG OSSEOTITE®<br>Implants. |

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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 a circular seal with the words "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 9200 Corporate Boulevard Rockville MD 20850

## NOV - 7 2003

Ms. Tamara Nelson International Regulatory Affairs Specialist Implant Innovations, Incorporation 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K033430

Trade/Device Name: 31 TG Osseotite Wide Implants, Models TG685, TG611, TG613 Regulation Number: 872.3640 Regulation Name: Dental Implant Regulatory Class: III Product Code: DZE Dated: October 27, 2003 Received: October 28, 2003

Dear Ms. Nelson:

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 - Ms. Nelson

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 (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.

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]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susie Runons

Sy 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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510(k) Number (if known): K033430

Device Name: 3i TG OSSEOTITE® Wide Implants

## Indications for Use:

3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number: | 1033430 |
|----------------|---------|
|----------------|---------|

| Prescription Use: | <div></div> | OR | Over the Counter Use: | <div></div> |
|----------------------|-------------|----|-----------------------|-------------|
| (Per 21 CFR 801.109) | | | | |