STERI-OSS APICAL IMPLANT

K960398 · Steri-Oss, Inc. · DZE · Aug 1, 1996 · Dental

Device Facts

• Record ID: K960398
• Device Name: STERI-OSS APICAL IMPLANT
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.

Device Story

Steri-Oss Apical Implant functions as endosseous dental implant replacing natural tooth root. Device provides foundation for prosthetic abutments/crowns to restore masticatory function. Implant features threaded design, 3.8 mm width, lengths 8-18 mm, and 50% hydroxylapatite coating on apical threads. Used by dental professionals in clinical settings. Benefits patient by providing stable anchorage for bridgework and dentures.

Clinical Evidence

Bench testing only. Performance data includes static tensile, static 90° transverse, static 30° compression, and 30° compression fatigue testing conducted on the predicate device.

Technological Characteristics

Material: Titanium alloy with 50% hydroxylapatite coating on apical threads. Dimensions: 3.8 mm width; 8, 10, 12, 14, 16, 18 mm lengths. Design: Threaded root form with flat superior aspect. Sterilization: Sterile.

Indications for Use

Indicated for patients requiring dental restoration in the mandible or maxilla; serves as artificial root structure for bridgework and denture retention.

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 Titanium Screw Series Implants

Submission Summary (Full Text)

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K 960398

20

Original 510(k)
Steri-Oss Apical Implant

Section 7
letterhead
AUG - 1 1996
510(k) Summary

## Manufacturer Information:

Submitter's Name: Steri-Oss
Address: 22895 Eastpark Drive
Yorba Linda, CA 92687
U.S.A.
Contact's Name: Paul Gasser
Regulatory Affairs Specialist
Phone: [phone]
Date Prepared: January 1996

## Device Names:

Common Name: Endosseous dental implant
Trade Name: Steri-Oss Apical Implant
Classification Name: Endosseous implant

## Predicate Device:

Substantial equivalence is claimed to Steri-Oss’ Titanium Screw Series Implants.

## Device Description:

How device functions: The Steri-Oss implant functions by serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed.

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Steri-Oss, Inc. - January 1996

Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92687 • [phone] Fax: [phone] • [phone]

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Original 510(k)
Steri-Oss Apical Implant

## Device Description (cont.):

Scientific concepts: Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown.

Characteristics: The implant is threaded with a 3.8 mm width and an 8, 10, 12, 14, 16 and 18 mm length. The superior aspect is flat. Half of the implant is coated with hydroxylapatite.

## Intended Use:

The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.

Steri-Oss, Inc. - January 1996

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Original 510(k)
Steri-Oss Apical Implant

## Comparison to Predicate:

The following table provides a comparison of the technological characteristics of the Steri-Oss implant to the predicate.

| Item | Predicate | Apical Implant |
| --- | --- | --- |
| Material | Titanium alloy | Titanium alloy and HA |
| Coating Configuration | All but 1 mm neck (8 mm length) | 50% of apical threads |
| | All but 2 mm neck (10, 12, 14, 16, 18 mm lengths) | |
| Width (mm) | 3.8 | Same |
| Length (mm) | 8, 10, 12, 14, 16, 18 | Same |
| Design | Threaded root form with flat superior aspect | Same |
| Packaging | Double vial | Same |
| Sterility | Sterile | Same |

## Performance Data:

Static tensile, static 90° transverse, static 30° compression and 30° compression fatigue were conducted on the predicate.

Steri-Oss, Inc. - January 1996