NANOTITE DENTAL IMPLANTS

K062432 · Implant Innovations, Inc. · DZE · Feb 22, 2007 · Dental

Device Facts

• Record ID: K062432
• Device Name: NANOTITE DENTAL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 22, 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 maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

Device Story

NanoTite Dental Implants are endosseous dental implants designed for surgical placement in the jaw. The device features a proprietary OSSEOTITE acid-etched surface enhanced with nanometer-scale calcium phosphate crystals. Available in tapered and parallel-walled/straight designs with external hex or internal connections. Used by dental surgeons to provide prosthetic attachment for single teeth, edentulous spans, bridgework, or overdentures. Immediate loading is supported under specific clinical conditions (minimum 4 splinted implants, ≥10mm length, anterior placement). The device serves as a foundation for dental prosthetics, benefiting patients by restoring oral function and aesthetics.

Clinical Evidence

Bench testing only. Laboratory testing conducted to determine device functionality and conformance to design input requirements and FDA Class II special controls guidance for root-form endosseous dental implants. Risk analysis performed per ISO 14971.

Technological Characteristics

Endosseous dental implant; OSSEOTITE acid-etched surface with nanometer-scale calcium phosphate crystal deposition. Designs: tapered and parallel-walled/straight. Connections: external hex or internal. Materials: titanium (implants/cover screws). Standards: ISO 14971 (risk analysis).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for single tooth restorations, partially or fully edentulous spans, fixed or removable bridgework, or overdenture retention. Immediate loading indicated for ≥4 splinted implants (≥10mm length) in the anterior maxilla/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 (K051461)

Reference Devices

• OSSEOTITE
• OSSEOTITE NT
• OSSEOTITE Certain
• OSSEOTITE Certain NT
• Prevail Implants

Submission Summary (Full Text)

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Implant Innovations, Inc. 510(k) Premarket Notification –NanoTite™ Dental Implants

. . . .

K062432

### 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 | FEB 2 2 2007 | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| 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 | August 18, 2006 | | |
| Device Name | NanoTite™ Dental Implants | | |
| Classification Name | Endosseous Dental Implants | | |
| Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3640 | | |
| Predicate<br>Devices | 3i OSSEOTITE Dental Implants<br>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 NanoTite Dental Implants, hereinafter referred to as<br>NanoTite Dental Implants, are the same dental implants<br>referred to as "3i Nano CaP OSSEOTITE" Dental<br>Implants, subject of the predict device submission<br>K051461. The NanoTite Dental Implants are provided<br>with the proprietary OSSEOTITE acid-etched surface<br>further treated with a deposition of nanometer scale<br>crystals of calcium phosphate. Implants are offered in | | |

મકાસ 0009 ុង

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Implant Innovations, Inc. 510(k) Premarket Notification -NanoTite™ Dental Implants

both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Indications for 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 maxilla and/or mandible and splinted in the anterior region, immediate loading is indicated. Technological The design features and functions are similar to the currently available OSSEOTITE, OSSEOTITE NT, Characteristics OSSEOTITE Certain, OSSEOTITE Certain NT, and Prevail Implants, and 3i Implant Innovations implants and cover screws. The OSSEOTITE surface is enhanced by the presence of nanometer scale crystals of calcium phosphate. Performance Testing Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Results from all of these tests were included in the premarket notification submission for the predicate devices, K051461. Specific performance claims which are the subject of this premarket notification are based on reports contained in

The NanoTite Dental Implants are substantially equivalent to the dental implants described in the Conclusion premarket notification submission for the predicate devices, K051461.

Sections 18 and 19.

0010

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the left.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 2 2 2007

Re: K062432

Trade/Device Name: NanoTite™ Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 13, 2007 Received: February 15, 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, pa 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 807.0 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,

Chiu-Ling, Ph.D.

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): Kow 2432

Device Name: NanoTite™ Dental 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 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 overder of mech

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

tim Mulig Ron MSR

KU62432

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