STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT

K963224 · Steri-Oss, Inc. · DZE · Nov 14, 1996 · Dental

Device Facts

• Record ID: K963224
• Device Name: STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.

Device Story

Endosseous dental implants serve as artificial roots to support prosthetic devices (crowns/bridges) for restoring chewing function. Implants are surgically placed into the jaw bone using a single-stage surgical placement method. The device provides a stable foundation for abutments and subsequent prosthetic restoration. Used in dental clinics by dentists. Benefits include restoration of masticatory function for patients with missing teeth.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics to previously cleared devices.

Technological Characteristics

Materials: Titanium alloy, hydroxyapatite (HA) coating, or titanium plasma spray (TPS) coating. Configurations: Threaded or cylindrical, flat top or hex lock. Dimensions: 3.25-5.0 mm diameter, 8-18 mm length. Sterilization: Sterile. Energy source: None (mechanical).

Indications for Use

Indicated for patients who have lost natural dentition due to disease, trauma, or other causes, requiring restoration of 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 Titanium Alloy Screw Series Implant For Single Stage Surgical Placement (SSP) (K944158)

Submission Summary (Full Text)

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K903224

Steri-Oss Implants For Single Stage Placement 510(k)/SSP

SECTION 7: 510(k) SUMMARY

NOV 14 1996

## Letterhead

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: Jeff Hausheer, Ph.D. Regulatory Affairs

Telephone Number: 714-282-4800, extension 3815

Date Prepared: August 1996

## Device Names:

Common Name: Endosseous Dental Implant for Single Stage Surgical Placement

Trade Names: See appended list (page 4)

Classification Name: Endosseous Implant (all designs)

## Predicate Device:

Substantial equivalence is claimed to

Steri-Oss' Oss' "Titanium Alloy Screw Series Implant For Single Stage Surgical Placement ("SSP")". an uncoated 3.8-mm diameter threaded titanium alloy implant (510(k) number K944158, Steri-Oss catalog numbers 2208, 2210, 2212, 2214, 2216, and 2218).

## Device Description:

1) How The Device Functions:

Steri-Oss Single Stage Surgical Placement dental implants are designed to serve as supports for prosthetic devices intended to restore a patient's chewing function.

August 1996

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SECTION 7: 510(k) SUMMARY (continued)

## Device Description (continued):

### 2) Scientific Principles:

Natural teeth are anatomically composed of a root - the subgingival portion of the tooth - and a crown - that part of the tooth above the gum. Dental implants are intended to mimic the root portion of this structure to aid in restoration of chewing function in patients who have lost natural dentition through disease, trauma or other cause. Implants integrate into the jaw bone. By providing a stable foundation analogous to the root portion of a natural tooth, and in combination with an abutment structure (i.e., a foundation for an artificial crown), dental implants provide a platform upon which the dentist can build an artificial crown or bridge, thereby restoring the patient's ability to chew.

### 3) Physical Characteristics

The Steri-Oss Single Stage Surgical Placement implants are slightly tapered and vary in diameter from 3.25 millimeters to 5.0 millimeters (neck dimension) depending upon the specific implant design, and vary from 8 millimeters to 18 millimeters in length. They may have no coating or a coating consisting of titanium alloy or hydroxyapatite. Titanium or hydroxyapatite coatings are applied as a plasma spray. The implants are available in cylindrical or threaded configurations and have either a flat top or a hex lock configuration at the apical surface.

## Intended Use:

Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.

## Comparison to the Predicate Device(s):

Steri-Oss implants indicated for single stage surgical placement are identical in all aspects to corresponding implants cleared for marketing for placement using the two stage surgical placement method, including the materials from which they are fabricated, the fabrication methods, the physical dimensions and geometry, the method of sterilization, the type of packaging, and all other respects.

38

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# SECTION 7: 510(k) SUMMARY (continued)

The following table provides a comparison of the technological characteristics of the Steri-Oss implant and the predicate device

Product Comparison

| Characteristic | Predicate Device | Submission Device |
| --- | --- | --- |
| Body Material | Titanium alloy | Same |
| Coating Materials | None, or
HA or
TPS
(depending upon configuration) | Same |
| Design | Threaded or cylindrical | Same |
| Superior surface | Flat or Hex Lock | Same |
| Length (mm) | 8, 10, 12, 14, 16, 18 mm | Same |
| Diameter (mm) | 3.25, 3.8, 4.1/4.5, 5.0/4.5 mm | Same |
| Packaging | Double vial | Same |
| Sterility | Sterile | Same |

Page 3 of 4

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Page 4 of 4
10

# SECTION 7: 510(k) SUMMARY (continued)

## Trade Names:

1) Flat-top, threaded, HA-coated, 3.8-mm diameter SSP
2) Flat-top, cylinder, HA-coated, 3.25-mm diameter SSP
3) Flat-top, cylinder, HA-coated, 3.8-mm diameter SSP
4) Flat-top, cylinder, TPS-coated, 3.25-mm diameter SSP
5) Flat-top, cylinder, TPS-coated, 3.8-mm diameter SSP
6) Hex-lock, threaded, uncoated, 3.25-mm diameter SSP
7) Hex-lock, threaded, uncoated, 3.8-mm diameter SSP
8) Hex-lock, threaded, uncoated, 4.1-mm neck / 4.5-mm body diameter SSP
9) Hex-lock, threaded, uncoated, 5.0-mm neck / 4.5-mm body diameter SSP
10) Hex-lock, threaded, HA-coated, 3.25-mm diameter SSP
11) Hex-lock, threaded, HA-coated, 3.8-mm diameter SSP
12) Hex-lock, threaded, HA-coated, 4.1-mm neck / 4.5-mm body diameter SSP
13) Hex-lock, threaded, HA-coated, 5.0-mm neck / 4.5-mm body diameter SSP
14) Hex-lock, threaded, TPS coated, 3.25-mm diameter SSP
15) Hex-lock, threaded, TPS coated, 3.8-mm diameter SSP
16) Hex-lock, threaded, TPS coated, 5.0-mm neck/4.5-mm body diameter SSP
17) Hex-lock, cylinder, HA-coated, 3.25-mm diameter SSP
18) Hex-lock, cylinder, HA-coated, 3.8-mm diameter SSP
19) Hex-lock, cylinder, TPS coated, 3.25-mm diameter SSP
20) Hex-lock, cylinder, TPS coated, 3.8-mm diameter SSP