OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS

K031632 · Implant Innovations, Inc. · DZE · Sep 16, 2003 · Dental

Device Facts

• Record ID: K031632
• Device Name: OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

3i IOL Dental Implants are endosseous dental implants designed to mimic the shape and form of a natural tooth. The devices are available in both externally hexed and internally connected designs. They are surgically placed into the upper or lower jaw by a dental professional to serve as an anchor for prosthetic dental attachments. The device functions as a mechanical support structure for restorative dentistry.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Endosseous dental implant; tapered design; externally hexed or internally connected configurations; mimics natural tooth form. Materials and specific standards not detailed in provided text.

Indications for Use

Indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in patients requiring dental implants.

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® NTTM 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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Implant Innovations, Inc. 510(k) Premarket Notification – 3i IOL™ Dental Implants

K031632

## 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 23, 2003 |
| Device Name | <i>3i</i> IOLTM Implants |
| Classification Name | Endosseous Dental Implant |
| Device<br>Classification | Class III<br>Dental Devices Panel<br>21 CFR § 872.3640 |
| Predicate<br>Devices | K014235 - OSSEOTITE® NTTM Dental Implants<br>K972444 - <i>3i</i> Innovative Implants and Cover Screws<br>K935544 - Threaded Self-Tapping Threaded Implants<br>K980549 – OSSEOTITE Dental Implants<br>K983347 – OSSEOTITE Dental Implants<br>K022009 – <i>3i</i> Dental Implants |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and |

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| Device Description | The 3 <i>i</i> IOLTM Dental Implants are offered in both<br>externally hexed and internally connected designs. The<br>devices are tapered implants designed to mimic the shape<br>and form of a natural tooth. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | 3 <i>i</i> IOL Dental Implants are indicated for surgical<br>placement in the upper or lower jaw to provide a means for<br>prosthetic attachment. |
| Technological<br>Characteristics | The 3 <i>i</i> IOL Dental Implants contain<br>features and functions which are similar to the currently<br>available OSSEOTITE NTTM Implants and 3 <i>i</i> Innovative<br>Implants and Cover Screws. |
| Conclusion | The 3 <i>i</i> IOL Dental Implants are substantially equivalent to<br>the legally marketed OSSEOTITE NT Implants and 3 <i>i</i><br>Innovative Implants and Cover Screws. |

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Ms. Jacquelyn A. Hughes Director Regulatory Affairs Implant Innovations, Incorporation 4555 Riverside Drive Palm Brach Gardens, Florida 33410

Re: K031632

Trade/Device Name: Osseotite IOL™ Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: May 23, 2003 Received: June 26, 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 (OS) 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,

Susan Penroe

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): _ _ 031632

Device Name: 3i 1OL 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muluy for M.Se

(Division Sicn-Off) ision of Anasthesiclogy, General Hospital, Infection Control, Dental D

510(k) Number:

Prescription Use:
(Per 21 CFR 801.109)

OR

Over the Counter Use:_