OSSEOTITE DENTAL IMPLANTS

K013570 · Implant Innovations, Inc. · DZE · Dec 17, 2001 · Dental

Device Facts

• Record ID: K013570
• Device Name: OSSEOTITE DENTAL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Device Story

OSSEOTITE® dental implants are endosseous devices surgically placed in the jaw to support prosthetic attachments; intended to restore patient chewing function. The device is identical to previously cleared predicate implants. Clinical evidence supports the safety and efficacy of the implants, specifically regarding long-term cumulative survival rates in both smokers and non-smokers, justifying the removal of smoking-related warnings from the labeling.

Clinical Evidence

Meta-analysis of clinical data on OSSEOTITE® implants. Results showed no significant difference in long-term cumulative survival between smokers and non-smokers. Additionally, survival of OSSEOTITE® implants in smokers was found to be greater than that of 3i machined implants in smokers.

Technological Characteristics

Endosseous dental implants; identical to predicate devices (K983347, K980549, K935544). No specific material standards or software components described.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for prosthetic attachment to 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

• OSSEOTITE® Dental Implants (K983347)
• OSSEOTITE® Dental Implant System (K980549)
• 3i Standard Threaded/Self-Tapping Threaded Implant (K935544)

Submission Summary (Full Text)

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DEC 1 8 2001

K013570

## 510(k) Summary for the OSSEOTITE® Dental Implants

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Implant Innovations, Inc. (3i) |
| Contact Person | Jacquelyn A. Hughes, RAC<br>Director, Regulatory Affairs & Quality Assurance<br>Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, Florida 33410<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | October 26, 2001 |
| Name | OSSEOTITE® Dental Implants |
| Classification Names | Implants, Endosseous |
| Device Classification | Classification: Class III<br>Classification Panels: Dental<br>Regulation Number: 872.3640 |
| Predicate Devices | <ul><li>OSSEOTITE® Dental Implants, K983347 (cleared 1/99)</li><li>OSSEOTITE® Dental Implant System, K980549 (cleared 4/98)</li><li>3i Standard Threaded/Self-Tapping Threaded Implant, K935544 (cleared 3/95)</li></ul> |

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| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The proposed OSSEOTITE® implants are identical to the predicate implants<br>currently on the market, K983347, K980549, K935544. |
| Indications<br>for<br>Use | 3i dental implants are indicated for surgical placement in the upper or lower<br>jaw to provide a means for prosthetic attachment to restore a patient's<br>chewing function. |
| Technological<br>Characteristic | The proposed OSSEOTITE® implants are identical to the predicate implants<br>currently on the market, K983347, K980549, K935544. |
| Summary of<br>Testing<br>Supporting<br>the Change | 3i has conducted a meta-analysis of clinical data on the OSSEOTITE®<br>implants. The results indicate that there is no significant difference in the<br>long-term cumulative survival of the OSSEOTITE® in smokers and non-<br>smokers. A second analysis further demonstrates that the long-term survival<br>of OSSEOTITE® implants in smokers is greater than that of 3i machined<br>implants in smokers. Thus, these data also further support not including<br>smoking and tobacco use as a Warning or Precaution for the OSSEOTITE®<br>implants. |
| Conclusion | The OSSEOTITE® implants with revised Instructions for Use labeling are<br>substantially equivalent to the predicate OSSEOTITE® implants. |

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 82001

Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K013570

Trade/Device Name: Osseotite® Dental Implants Regulation Number: 872.3640 Regulation Name: Implants, Endosseous Regulatory Class: III Product Code: DZE Dated: November 27, 2001 Received: November 28, 2001

Dear Ms. Hughes:

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.

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.

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## Page 2 - Ms. Hughes

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: OSSEOTITE® Dental Implants

Indications For Use:

3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Runos

(Division Sign-Off) Division Sign Only Infection Control, the Caneral Hospital Devices -013510 r ============================================================================================================================================================================