3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS

K022009 · Implant Innovations, Inc. · DZE · Dec 30, 2002 · Dental

Device Facts

• Record ID: K022009
• Device Name: 3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implant Innovation's dental implant systems 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

3i Dental Implant Systems consist of titanium screw-form or cylinder implants, available in various diameters and lengths. Some variants feature a dual acid-etched surface treatment (OSSEOTITE) to increase surface roughness. Implants are surgically placed in the upper or lower jaw by dental professionals to provide an anchor for prosthetic attachments, restoring patient chewing function. Performance is influenced by physiological and anatomical factors, including bone quality and oral hygiene. Clinical data indicates enhanced performance of OSSEOTITE implants in patients with poor quality bone compared to other 3i implants.

Clinical Evidence

No new clinical trials were conducted for this submission. The document references existing clinical data demonstrating enhanced performance of OSSEOTITE® implants compared to other 3i implants specifically in patients with poor quality bone.

Technological Characteristics

Implants manufactured from titanium. Available in screw-form (threaded) or cylinder geometries. Surface treatment includes a dual acid-etched process to increase surface roughness. System is non-electronic and does not utilize software.

Indications for Use

Indicated for surgical placement in the upper or lower jaw to restore chewing function in patients requiring prosthetic attachment. Contraindicated in patients with insufficient jaw bone for implant stability or conditions precluding surgery.

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™ Implant System (K014265)
• OSSEOTITE® Dental Implants (K935544, K980549, K983347, K013570)
• 3i Dental Implant Systems (K874590)

Submission Summary (Full Text)

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K022009

Image /page/0/Picture/2 description: The image shows the logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" with the "i" resembling a tall, rectangular shape. Below the "3i" are the words "IMPLANT INNOVATIONS, INC." in a bold, sans-serif font, and beneath that, "A BIOMET COMPANY" is written in a smaller, similar font.

DEC 3 0 2002

# Summary of Safety & Effectiveness

- COMPANY: Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410
Jeannette G. Dailey, RAC Regulatory Affairs Manager Telephone: [phone] Fax: [phone] E-mail: [e-mail]

June 18, 2002

DATE PREPARED:

CONTACT:

NAME OF THE DEVICE:

CLASSIFICATION: DZE Class III

COMMON NAME:

PREDICATE DEVICES:

Endosseous Dental Implants

3i Dental Implant Systems

OSSEOTITE NT™ Implant System

- K014265 for clearance of the system on May . 16, 2002
OSSEOTITE® Dental Implants cleared for marketing via the following premarket notifications:

- . K935544 for an acid-etched process to create the OSSEOTITE brand surface cleared on March 13, 1995,
- K980549 for a performance claim cleared on ● April 28, 1998,
- K983347 for a performance claim cleared on ● January 1, 1999, and
- K013570 for Instructions for Use changes cleared on December 18, 2001.

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3i Dental Implant Systems

- K874590 for clearance of the system on May . 11, 1988.
#### DEVICE DESCRIPTION:

Implant Innovation's dental implant systems are available in a wide range of diameters 3i implants include screw-form (i.e., threaded) or cylinder; are and lengths. manufactured from titanium; and are coated or non-coated. The OSSEOTITE® brand implants have a special dual acid-etched treatment process to increase surface roughness.

### INDICATIONS FOR USE:

The Implant Innovation's dental implant systems 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.

#### CONTRAINDICATIONS:

Placement of 3i dental implants may be precluded by patient conditions that are contraindications for surgery.

3i implants should not be placed on patients where the remaining jaw bone is too diminished to provide adequate implant stability.

## WARNINGS

Excessive bone loss or breakage of implant may occur when an implant is loaded beyond its functional capability.

Physiological and anatomic conditions may negatively affect the performance of dental implants. This should be taken into consideration when placing dental implants in patients with the following*:

- . Poor quality bone
- Poor oral hygiene ●
- Medical conditions such as blood disorders or uncontrolled hormonal conditions .

* Clinical data have demonstrated enhanced performance of Osseotite® implants as compared to other 3i implants in patients with poor quality bone.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

#### Public Health Service

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2002

Ms. Jeannette G. Dailey Regulatory Affairs Manager Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K022009

Trade/Device Name: 3i Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 13, 2002 Received: December 16, 2002

Dear Ms. Dailey:

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 vour 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. Dailey

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]. 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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Implant Innovations, Inc. 510(k) Premarket Notification – Labeling Modification

K022009

Page _1

510(k) Number (if known): ___K022009

Device Name: 3i Dental Implant System

#### Indications for Use:

3i Dental Implant Systems 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)

Robert Sher DDS for Dr. Susan Runner

Division Sig Division of Anesthesiology. General Hospital. Infection Control, Dental Devi

510(k) Number: K022009

Prescription Use: (Per 21 CFR 801.109) OR

Over the Counter Use:_