FIXTURE MOUNT KIT

K963121 · Steri-Oss, Inc. · DZE · Nov 5, 1996 · Dental

Device Facts

• Record ID: K963121
• Device Name: FIXTURE MOUNT KIT
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The kit is indicated for use to assist in fixture placement.

Device Story

Steri-Oss Fixture Mount Kit assists clinicians in dental fixture placement. Kit contains surgical instruments used during procedure. Device functions as manual surgical aid. No automated processing or electronic output. Used in clinical dental settings by trained professionals.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Surgical kit containing instruments and tray. Materials: titanium, steel, and silicone. Non-sterile.

Indications for Use

Indicated for use in assisting dental fixture placement; patient population not specified.

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

• Nobelpharma Instrument set for fixture installation, SDIB 101

Submission Summary (Full Text)

{0}

STERI-OSS
A BAUSCH & LOMB Company
Original 510(k)
Fixture Mount Kit
K963Q1
NOV - 5 1996
29

# Section 7

## 510(k) Summary

### Manufacturer Information:

Submitter’s Name: Steri-Oss Inc.

Address: 22895 Eastpark Drive
Yorba Linda, CA 92887
U.S.A.

Contact’s Name: Paul Gasser
Regulatory Affairs Specialist

Phone: [phone]

Date Prepared: August 1996

### Device Names:

Common Name: Kit

Trade Name: Fixture Mount Kit

Classification Name: Surgical Kit - General

### Predicate Device:

Substantial equivalence is claimed to Nobelpharma’s Instrument set for fixture installation, SDIB 101.

### Device Description:

How device functions: The Steri-Oss kit is designed to assist in fixture placement.

Page 1 of 2
Steri-Oss Inc. - August 1996
Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92687 • [phone] Fax: [phone] • [phone]

{1}

Original 510(k)
Fixture Mount Kit

## Device Description (cont.):

Scientific concepts: Does not apply.

Characteristics: The tray is composed of titanium and the instruments are composed of titanium or steel.

## Intended Use:

The kit is indicated for use to assist in fixture placement.

## Comparison to Predicate:

The following table provides a comparison of the technological characteristic of the Steri-Oss kit to the predicate.

| Item | Predicate | Steri-Oss |
| --- | --- | --- |
| Material | Titanium | Titanium |
| | Steel | Steel |
| | Aluminum | Silicone |
| Sterility | Non-Sterile | Same |

## Performance Data:

Not applicable.

Steri-Oss Inc. - August 1996