STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT

K982400 · Steri-Oss, Inc. · EMA · Sep 23, 1998 · Dental

Device Facts

• Record ID: K982400
• Device Name: STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
• Applicant: Steri-Oss, Inc.
• Product Code: EMA · Dental
• Decision Date: Sep 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.

Device Story

Steri-Oss' ImProv Temporary Dental Cement is a two-part, resin-filled, anaerobic paste system used for temporary retention of crown and bridge prostheses. Provided in two syringe-like polyalkylene cylinders (10g each), the components self-cure upon mixing. Used in dental clinical settings by practitioners to lute prostheses to natural tooth abutments. The device functions as a temporary adhesive, facilitating the secure but reversible attachment of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-part, resin-filled, anaerobic self-curing dental cement. Provided in two polyalkylene syringe-like cylinders. No electronic components, software, or external energy sources.

Indications for Use

Indicated for the temporary cementation (luting) of crown and bridge prostheses to natural tooth abutments.

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' Untill Implant Cement (K972965)
• Scientific Pharmaceutical's Interim Cement (K884081)

Submission Summary (Full Text)

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

SEP 2 3 1998

Ka82400

Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission

## Section 6

## 510(k) Summary

### Manufacturer Information:

Submitter's Name: Steri-Oss Inc. 22895 Eastpark Drive Address: Yorba Linda, CA 92887 U.S.A.

> Jeff Hausheer, Ph.D. Contact's Name: Requlatory Affairs Specialist

714-282-4800 Phone:

714-988-9236 Fax:

Date Prepared:

July 1998

Device Name:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Crown and Bridge Cement Common Name: Trade Name: Steri-Oss' ImProv Temporary Dental Cement Classification Name: Dental Cement

## Predicate Device:

Substantial equivalence is claimed to Steri-Oss' Untill Implant Cement (510(k) K972965), cleared on November 7, 1997, and intended for cementation (luting) of an implant prosthesis, and to Scientific Pharmaceutical's Interim Cement (510k) K884081, cleared on December 2, 1988, and intended for cementation (luting) of crown and bridge prostheses to natural tooth abutments .

Nateeth.doc

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

Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission

### Section 6 (continued)

### 510(k) Summary

Device Description:

How the device functions:

Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.

#### Intended Use:

Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.

#### Comparison to Predicate

The following table provides a comparison of the technological characteristics of Steri-Oss' ImProv Temporary Dental Cement to the predicate devices.

| Characteristic | Predicate 1: Interim Cement | Predicate 2: Until Implant Cement | New Product: ImProv |
|----------------|-----------------------------|-----------------------------------|---------------------|
| Curing | Anaerobic Self-curing | Anaerobic Self-curing | Same |
| System | Two part system | Two part system | Same |
| Cement Base | Resin filled | Resin filled | Same |

Performance Data

Not applicable

Page 2 of 2

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1998

Jeff Hausheer, Ph.D. Regulatory Affairs Specialist Steri-Oss, Incorporated 22895 Eastpark Drive Yorba Linda, California 92887

Re : K982400 Steri-Oss' ImProv Temporary Dental Cement Trade Name: Regulatory Class: II Product Code: EMA Dated: July 10, 1998 Received: July 10, 1998

Dear Dr. Hausheer:

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 of the Act. The general controls provisions 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. ਖ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through-542 of ------

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

Page 2 - Dr. Hausheer

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 leqally 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 regulation (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,

Susan Kunney

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Steri-Oss' ImProv Temporary Dental Cement Original 510(k) Submission

### Section 8

## Indications for Use

Page _1_of _1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Steri-Oss' ImProv Temporary Dental Cement

Indications For Use:

Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Susan Russo</i> |
|---------------|----------------------------------------|
| | (Division Sign-Off) |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | K982400 |

| Prescription Use | <span style="text-decoration: underline;">✓</span> |
|------------------|----------------------------------------------------|
|------------------|----------------------------------------------------|

OR Over-The-Counter Use _____ (Per 21 CFR 801.109)

(Optional Format 1-2-96)