STERI-OSS TEMPORARY IMPLANT CEMENT

K963078 · Steri-Oss, Inc. · EMA · Sep 10, 1996 · Dental

Device Facts

• Record ID: K963078
• Device Name: STERI-OSS TEMPORARY IMPLANT CEMENT
• Applicant: Steri-Oss, Inc.
• Product Code: EMA · Dental
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cement is indicated for use in the cementing (luting) of a implant prosthesis.

Device Story

Steri-Oss Temporary Implant Cement; two-part polyalkylene resin paste; self-curing upon mixing; used by dentists for retention of implant prostheses; provides temporary fixation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Two-part polyalkylene resin paste; self-curing; dental cement.

Indications for Use

Indicated for cementing (luting) of implant prostheses in dental patients.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Septodont’s Resiment resin cement

Submission Summary (Full Text)

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SEP 10 1996
K963078

Steri-Oss Temporary Implant Cement
Orginal 510(k) Submission

## Section 6

## 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: Don Kennard
Regulatory Affairs

Phone: [phone]

Fax: [phone]

Date Prepared: August 1996

### Devices Names:

Common Name: Dental Cement

Trade Name: Steri-Oss Temporary Implant Cement

Classification Name: Dental Cement

### Predicate Device:

Substantial equivalence is claimed to Septodont’s Resiment resin cement.

### Device Description:

How the device functions: The Steri-Oss Temporary Implant Cement serves as a cement for retention of implant prosthesis. The cement is a two part paste which is self cured on mixing and application. The product is provided in two 10 gram containers of polyalkylene material.

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# Steri-Oss Temporary Implant Cement
## Orginal 510(k) Submission

### Intended Use:

The cement is indicated for use in the cementing (luting) of a implant prosthesis.

### Comparison to Predicate

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

| Item | Predicate | Steri-Oss |
| --- | --- | --- |
| Curing | Self Cured | Self Cured |
| System | Two part system | Two part system |
| Cement base | Resin filled | Resin filled |

### Performance Data

Not applicable, 510(k) requests a indication.