KERR COMPOMER

K974105 · Sybron Dental Specialties, Inc. · EBF · Jan 9, 1998 · Dental

Device Facts

• Record ID: K974105
• Device Name: KERR COMPOMER
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Kerr Compomer is a light-curable dental restorative material containing a fluoride releasing agent intended to be used in dentistry as a filling material for all class cavities.

Device Story

Kerr Compomer is a single-component, light-curable dental restorative material formulated with a fluoride-releasing agent. It is supplied in a Unidose delivery system and available in Vita shades. The device is intended for professional use by dentists in a clinical setting for the restoration of all classes of dental cavities. Upon application into the cavity preparation, the material is cured using a dental light-curing unit. The fluoride release is intended to provide therapeutic benefit within the restored tooth structure. The device functions as a direct restorative material to replace lost tooth structure and restore function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-component, light-curable resin-based dental restorative material. Contains fluoride-releasing agents. Delivered via Unidose system. Available in Vita shades. Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for use as a dental filling material for all class cavities in patients requiring dental restoration.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Dyract (Dentsply)
• Compoglass (Vivadent)

Submission Summary (Full Text)

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

R974105

# JAN - 9 1998

# Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Wendy A. Urtel - Contact Person

October 1997 Date Summary Prepared:

### Device Name:

- Trade Name Kerr Compomer .
- Common Name Light-Curable Dental Restorative Material .
- Classification Name Tooth Shade Resin Material, 21 CFR § 872.3690 ●

# Devices for Which Substantial Equivalence is Claimed:

- Dyract, Dentsply .
- Compoglass, Vivadent ●

#### Device Description:

The device is a single-component light-curable dental restorative material that contains a fluoride releasing agent used for the restoration of all class cavities. Kerr Compomer is available in Vita® shading in a Unidose delivery system.

### Intended Use of the Device:

The intended use of Kerr Compomer is to be a light-curable dental restorative material containing a fluoride releasing agent that is used in dentistry as a filling material for all class cavities.

## Substantial Equivalence:

The dental restorative material is substantially equivalent to several other legally marketed devices in the United States. The dental restorative materials marketed by Dentsply and Vivadent function in a manner similar to and is intended for the same use as the product manufactured by Kerr\Dental Materials Center.

®Vita is a registered trademark of Vita Zahnfabrik.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wendy A. Urtel Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667

Re : K974105 Kerr Compomer Trade Name: Regulatory Class: II Product Code: EBF October 29, 1997 Dated: October 31, 1997 Received:

Dear Ms. Urtel:

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. ਰ substantially equivalent determination assumes compliance with ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

JAN - 9 1000

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

Page 2 - Ms. Urtel

not affect any obligation you might have under sections 531 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 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,

Timothy A. Ulatowski

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

Enclosure

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

Page **_ of _**

| 510(k) Number (if known): | K974105 |
|---------------------------|----------------|
| Device Name: | Kerr Compomers |

Indications For Use:

Kerr Compomer is a light-curable dental restorative material containing a fluoride releasing agent intended to be used in dentistry as a filling material for all class cavities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rimmer

(Division Sign-Off) Division of Dental, Info and General Hospital De a 7410s 510(k) Number

Prescription Use y a (Per 21 CFR 801.109)

OR

Over-The-Counter Use No

(Optional Format 1-2-96)