STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM

K973402 · Steri-Oss, Inc. · DZE · Nov 26, 1997 · Dental

Device Facts

• Record ID: K973402
• Device Name: STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for this device system is to serve as support for prosthetic devices to restore patient chewing functions.

Device Story

System comprises 3.25 mm diameter endosseous dental implants, healing screws, healing abutments, and abutments. Implants serve as artificial tooth roots; abutments/prostheses serve as crowns. Healing components protect internal threads and expand gingival tissue during healing. Used by dental professionals to restore masticatory function. Titanium alloy construction; tapered, threaded design with superior external hex. Components are anodized magenta. No clinical data provided.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Titanium alloy endosseous dental implants; 3.25 mm diameter; 10-16 mm length. Tapered, threaded design with superior external hex. Surface anodized magenta. Sterile.

Indications for Use

Indicated for patients requiring prosthetic support to restore chewing function via endosseous 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

• Steri-Oss Replace Implants, Healing Screws, Healing Abutments, and Abutments (K964220)
• Steri-Oss (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant (K911592)

Submission Summary (Full Text)

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Section 6

K973402

## 510(k) Summary

### Manufacturer Information:

| Submitter's Name: | Steri-Oss Inc. |
|----------------------|------------------------------------------------------|
| Submitter's Address: | 22895 Eastpark Drive<br>Yorba Linda, CA 92887<br>USA |
| Contact's Name: | Jeff Hausheer, Ph.D. |
| Contact's Telephone: | 714-282-4800, extension 3815 |
| Date Prepared: | September 1997 |

#### Device Name:

| Common Name: | Prosthetic Dental Implant System |
|----------------------|-------------------------------------------------|
| Trade Name: | Steri-Oss 3.25 mm Replace Dental Implant System |
| Classification Name: | Endosseous dental implant |

### Predicate Device:

Substantial equivalence is claimed to Steri-Oss' Replace Implants, Healing Screws, Healing Abutments, and Abutments (K964220) and to Steri-Oss' (3.25 mm diameter) Titanium Plasma Sprayed Cylindrical Implant (K911592).

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## Section 6 510(k) Summary

### Device Description:

#### How The Device Functions:

Individual components fulfill the following purposes:

Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.

Steri-Oss 3.25 mm Replace Healing Screw: This device is designed to protect the internal threads of the implant during healing.

Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.

Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.

#### Scientific Concepts:

Natural dentition is composed of a root (subgingival) and a crown (supragingival). Endosseous dental implant designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The subject implant is designed to serve as the root of the artificial tooth and the abutment/prosthesis is designed to serve as the crown. The healing screw and healing abutment are intermediary devices which serve to permit satisfactory completion of the implant healing/restoration process.

#### Device Characteristics:

The implants are 3.25 mm in diameter, are 10 to 16 mm in length, and are fabricated from titanium alloy. They are tapered, threaded, and have a superior external hex. The healing screw, healing abutment, and abutment are also fabricated from titanium alloy. Portions of the surface of each of the components are anodized magenta in color.

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### Section 6

## 510(k) Summary

#### Intended Use:

The intended use for this device system is to serve as support for prosthetic devices to restore patient chewing functions.

#### Comparison to Predicate:

The following table provides a comparison of the principle technological characteristics of the 3.25mm Replace Implant System and the predicate.

| Specification/<br>Characteristic | Predicate:<br>Steri-Oss Replace<br>Implant | New Product:<br>Steri-Oss 3.25 mm<br>Replace Dental Implant |
|----------------------------------|--------------------------------------------|-------------------------------------------------------------|
| Material | Titanium | Same |
| Surface<br>Characteristics | Color-coded | Same |
| Sterility | Sterile | Sterile |

# Comparison to Predicates:

#### Performance Data:

Not applicable.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Jeff Hausheer, Ph.D. ·Regulatory Affairs Specialist Steri-Oss, Incorporated 22895 East Park Drive Yorba Linda, California 92687

K973402 Re : Steri-Oss 3.25mm Replace Dental Implant Trade Name: System Requlatory Class: III Product Code: DZE September 8, 1997 Dated: Received: September 9, 1997

Dear Dr. Hausheer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realour bota in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Hausheer

through 542 of the Act for devices under the Electronic chrough 542 or the not in provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debtired in form of equivalence of your device to a legally marketed predicate device results in a classification for your marrees 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation entifica, Mibbianding by Solerseneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim Quy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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Section 9

## Indications for Use

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

3.25 mm Replace Dental Implant System

Indications For Use: The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

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

WGongurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device

510(k) Number 673402

Prescription Use

OR Over-The-Counter Use (Per 21 CFR 801.109)

Per 21 CFR 801.109)

(Optional Format 1-2-96)

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