← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K963078

# STERI-OSS TEMPORARY IMPLANT CEMENT (K963078)

_Steri-Oss, Inc. · EMA · Sep 10, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963078

## Device Facts

- **Applicant:** Steri-Oss, Inc.
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** Sep 10, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for 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.

## Regulatory 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: 714-282-4811

Fax: 714-988-9236

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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963078](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K963078)

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