OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE

K063286 · Implant Innovations, Inc. · DZE · Apr 24, 2007 · Dental

Device Facts

• Record ID: K063286
• Device Name: OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Device Story

3i OSSEOTITE Dental Implants are endosseous implants featuring a proprietary acid-etched surface; available in tapered, parallel-walled/straight, and trans-gingival designs with external or internal hex connections. Diameters range from 3.25mm to 6.0mm; lengths from 7mm to 20mm. Used by dental surgeons for prosthetic attachment in jaw restorations. Implants provide a foundation for single teeth, bridgework, or overdentures. Immediate loading is supported under specific clinical conditions (minimum 4 implants, ≥10mm, splinted in anterior mandible). Device benefits include osseointegration and stable prosthetic support.

Clinical Evidence

No new clinical data provided. Performance claims for specific indications (poor bone, early loading, smoking, immediate loading) rely on clinical data previously submitted and cleared in predicate device notifications (K980549, K983347, K022009, K030164). Bench testing conducted to confirm functionality and conformance to FDA Class II special controls guidance for root-form endosseous dental implants.

Technological Characteristics

Endosseous dental implants with proprietary acid-etched surface. Designs include tapered, parallel-walled/straight, and trans-gingival. Connections include external and internal hex. Diameters: 3.25, 3.75, 4.0, 5.0, 6.0 mm; Lengths: 7-20 mm. Risk analysis performed per ISO 14971.

Indications for Use

Indicated for patients requiring dental restoration in the upper or lower jaw, including single tooth, partially or fully edentulous spans, fixed or removable bridgework, and overdenture retention. Immediate loading indicated for patients with at least 4 implants (≥10mm length) splinted in the anterior mandible.

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 Dental Implants (K874590)
• 3i OSSEOTITE Dental Implants (K935544)
• 3i OSSEOTITE Dental Implants (K972444)
• 3i OSSEOTITE Dental Implants (K980549)
• 3i OSSEOTITE Dental Implants (K983347)
• 3i OSSEOTITE Dental Implants (K992334)
• 3i OSSEOTITE Dental Implants (K014235)
• 3i OSSEOTITE Dental Implants (K022009)
• 3i OSSEOTITE Dental Implants (K030164)
• 3i OSSEOTITE Dental Implants (K033430)
• 3i OSSEOTITE Dental Implants (K051461)

Submission Summary (Full Text)

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# K063286

#### 510(k) Summary

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 & 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 | October 27, 2006 |
| Device Name | <i>3i OSSEOTITE®</i> Dental Implants |
| Classification Name | Endosseous Dental Implants |
| Device Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3640 |
| Predicate Devices | <i>3i OSSEOTITE</i> Dental Implants<br>K874590, K935544, K972444, K980549, K983347,<br>K992334, K014235, K022009, K030164,<br>K033430, K051461 |
| 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 3i OSSEOTITE® Dental Implants are provided<br>with the proprietary OSSEOTITE acid-etched surface<br>which has been in commercial distribution since market<br>clearance in 1995. Implants are offered in tapered and<br>parallel-walled/straight designs, each design providing<br>offerings for external hex connections. Additionally, the<br>implants are offered in a trans-gingival design with an<br>internal connection Implants are offered in diameters of<br>3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm<br>to 20 mm. size appropriate cover screws are offered with<br>each implant. |
| Indications for Use | 3i dental implants are intended for surgical placement in<br>the upper or lower jaw to provide a means for prosthetic<br>attachment in single tooth restorations and in partially or<br>fully edentulous spans with multiple single teeth, or as a<br>terminal or intermediary abutment for fixed or removable<br>bridework, and to retain overdentures. |
| | In addition, when a minimum of 4 implants, ≥ 10mm in<br>length, are placed in the mandible and splinted in the<br>anterior region, immediate loading is indicated. |
| Technological<br>Characteristics | The design features and functions are identical to the<br>currently available OSSEOTITE, OSSEOTITE NT®,<br>OSSEOTITE XP® and TG OSSEOTITE®, and 3i<br>Implant Innovations implants and cover screws. |
| Performance Testing | Laboratory testing was conducted to determine device<br>functionality and conformance to design input<br>requirements, as well as FDA's Class II special controls<br>guidance document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments. Risk<br>analysis was conducted in accordance with ISO 14971.<br>Specific performance claims for enhanced performance<br>in poor bone (K980549), early loading (K983347), and<br>use in smokers (K022009), and immediate loading<br>(K030164) have received market clearance based on the<br>OSSEOTITE clinical data in the respective submissions. |
| Conclusion | The 3i OSSEOTITE Dental Implants are substantially<br>equivalent to the dental implants described in the<br>premarket notification submissions for the predicate |

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Implant Innovations, Inc. 510(k) Premarket Notification -3i OSSEOTITE®Dental Implants

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Implant Innovations, Inc. 510(k) Premarket Notification -3i OSSEOTITE®Dental Implants

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devices K879450, K935544, K972444, K992334, K980549, K983347, K014235, K022009, K030164, K033430 , K051461.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles three abstract human profiles or figures, stacked or layered on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 2 4 2007

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

Re: K063286

Trade/Device Name: OSSEOTITE® Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 12, 2007 Received: April 13, 2007

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/industry/support/index.html.

> Sincerely yours. unne

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): Ko 63286

Device Name: OSSEOTITE® Dental Implants

Indications for Use:

31 dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Suarez

Hostolona, Canaral Hospical on Control, Den k) Number ..

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