STERI-OSS UNTIL IMPLANT CEMENT

K972965 · Steri-Oss, Inc. · EMA · Nov 7, 1997 · Dental

Device Facts

• Record ID: K972965
• Device Name: STERI-OSS UNTIL IMPLANT CEMENT
• Applicant: Steri-Oss, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

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

Device Story

Steri-Oss Until Implant Cement is a two-part, resin-filled polyalkylene dental cement. It functions as a luting agent for the retention of implant prostheses. The material is self-cured upon mixing. It is intended for use by dental professionals in a clinical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison.

Technological Characteristics

Two-part system; resin-filled polyalkylene cement; self-curing mechanism.

Indications for Use

Indicated for cementing (luting) of an implant prosthesis.

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

• Steri-Oss Temporary cement

Submission Summary (Full Text)

{0}------------------------------------------------

K9729165

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

NOV - 7 1997

## Section 6

Summary 510 (k)

Manufacturer Information:

| Submitter's Name: | Steri-Oss Inc. |
|-------------------|---------------------------------------------------------|
| Address: | 22895 Eastpark Drive<br>Yorba Linda, CA 92887<br>U.S.A. |
| Contact's Name: | Don Kennard<br>Regulatory Affairs |
| Phone: | 714-282-4811 |

714-988-9236 Fax:

August 1997 Date Prepared:

Devices Names:

| Common Name: | Dental Cement |
|--------------|--------------------------------|
| Trade Name: | Steri-Oss Until Implant Cement |

Classification Name: Dental Cement

Predicate Device:

Substantial equivalence is claimed to Steri-Oss Temporary cement.

Device Description:

How the device functions: The Steri-Oss Until Implant How the device functions. This bettention of implant prosthesis.
Cement serves as a cement for retention of armund on mixing cement serves as a cement roll - that is self cured on mixing The cement is a cwo pars pars provided in two 10 gram containers of polyalkylene material.

{1}------------------------------------------------

Steri-Oss Until 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<br>(Steri-Oss Temporary) | Steri-Oss<br>(Until) |
|-------------|------------------------------------|----------------------|
| Curing | Self Cured | Self Cured |
| System | Two part system | Two part system |
| Cement base | Resin filled | Resin filled |

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES --------

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Don Kennard Regulatory Affairs Steri-Oss, Incorporated 22895 East Park Drive Yorba Linda, California 92687

K972965 Re : Steri-Oss Until Implant Cement Trade Name: Requlatory Class: II Product Code: EMA August 8, 1997 Dated: Received: August 11, 1997

Dear Mr. Kennard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

NOV - 7 1997

{3}------------------------------------------------

Page 2 - Mr. Kennard

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

{4}------------------------------------------------

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

## Section 7

Indications for use

KS72968 510 (k) Number

Device Name: Steri-Oss Until Implant Cement

Indications for Use:

Steri-Oss Until . Implant Cement is indicated_ for .... cementing (luting) of a implant prosthesis.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swann Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number KA729165

Prescription Use ← (Per 21 CFR 801.109)

OR

Over the Counter Use (Optional Format 1-2-96)

21