OSSEOTITE NT CERTAIN IMPLANTS

K031475 · Implant Innovations, Inc. · DZE · Jul 28, 2003 · Dental

Device Facts

• Record ID: K031475
• Device Name: OSSEOTITE NT CERTAIN IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OSSEOTITE NT Certain 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 NT CERTAIN Implants are internally connected, tapered endosseous dental implants designed to mimic natural tooth form. Used by dental professionals for surgical placement in the upper or lower jaw; provides a foundation for prosthetic attachments to restore patient chewing function. Device functions as a mechanical anchor within the bone.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant; internally connected, tapered design; mimics natural tooth form. Class III device (21 CFR 872.3640).

Indications for Use

Indicated for surgical placement in the upper or lower jaw of patients requiring 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 NT Dental Implants (K014235)
• 3i Innovative Implants and Cover Screws (K972444)
• Threaded Self-Tapping Threaded Implants (K935544)
• OSSEOTITE Dental Implants (K980549)
• OSSEOTITE Dental Implants (K983347)
• 3i Dental Implants (K022009)

Submission Summary (Full Text)

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JUL 288 2003

#### Implant Innovations, Inc. Thiplant Innovations, Inc.
510(k) Premarket Notification - OSSEOTITE NT™ CERTAIN™ Implants

## 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 | Jacquelyn A. Hughes, RAC<br>Director, Regulatory Affairs and Quality Assurance<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 | May 8, 2003 |
| Device Name | OSSEOTITE NT™ CERTAIN™ Implants |
| Classification Name | Endosseous Dental Implant |
| Device Classification | Class III<br>Dental Devices Panel<br>21 CFR § 872.3640 |
| Predicate Devices | K014235 - OSSEOTITE NT™ Dental Implants<br>K972444 - 3i Innovative Implants and Cover Screws<br>K935544 - Threaded Self-Tapping Threaded Implants<br>K980549 - OSSEOTITE Dental Implants<br>K983347 - OSSEOTITE Dental Implants<br>K022009 – 3i Dental Implants |
| 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 OSSEOTITE NT Certain Implants are internally<br>connected, tapered implants designed to mimic the shape<br>and form of a natural tooth. |

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| Indications for<br>Use | The OSSEOTITE NT Certain Implants are<br>indicated for surgical placement in the upper or lower jaw<br>to provide a means for prosthetic attachment to restore a<br>patient's chewing function. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The OSSEOTITE NT Certain Implants contain<br>features and functions which are similar to the currently<br>available OSSEOTITE NTTM Implants and 3i Innovative<br>Implants and Cover Screws. |
| Conclusion | The OSSEOTITE NT Certain Implants are substantially<br>equivalent to the legally marketed OSSEOTITE<br>NTImplants and 3i Innovative Implants and Cover Screws. |

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

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

Re: K031475

Trade/Device Name: Osseotite NTTM Certan™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 8, 2003 Received: May 9, 2003

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.

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Page 2 - Ms. Hughes

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,

Patricia Cuariteffer

Susan Runner, DDS, MA Interim 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): _K03/475

Device Name: OSSEOTITE NT™ CERTAIN™ Implants

### Indications for Use:

3i dental implants are intended 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)

MKE for MSR

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

510(k) Number: _

OR

<031475

Prescription Use:
(Per 21 CFR 801.109)

Over the Counter Use:_