PREMISE

K032921 · Sybron Dental Specialties, Inc. · EBF · Nov 13, 2003 · Dental

Device Facts

• Record ID: K032921
• Device Name: PREMISE
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Premise is a dental composite restorative material intended to be used in all classes of cavites.

Device Story

Premise is a light-cured, resin-based composite dental restorative material. It utilizes three types of fillers to achieve high polishability, high mechanical strength, and reduced polymerization shrinkage. The device is intended for direct placement in all classes of dental cavities. It is used by dental professionals in a clinical setting to restore tooth structure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Light-cured, resin-based composite dental restorative material. Incorporates three types of fillers to enhance mechanical strength, polishability, and reduce polymerization shrinkage. Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for use in all classes of dental cavities as a restorative material.

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

• Kerr Dental Materials Center, Point 4 Modified

Submission Summary (Full Text)

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K032921

Image /page/0/Picture/1 description: The image shows the text "K032921" in the upper left corner, followed by the logo for "sds" in the upper right. Below the logo is the text "SYBRON, DENTAL SPECIALTIES". The bottom of the image contains the text "Section III - 510(k) Summary of Safety and Effectiveness".

NOV 1 3 2003

Submitter:

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

Date Summary Prepared: September 2003

## Device Name:

- Trade Name Premise ●
- Common Name - Dental Composite Restorative Material
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●

### Devices for Which Substantial Equivalence is Claimed:

- Kerr Dental Materials Center, Point 4 Modified ●
### Device Description:

The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.

### Intended Use of the Device:

The intended use of Premise is for use in all classes of cavities.

### Substantial Equivalence:

Premise is substantially equivalent to other legally marketed devices in the United States. Premise functions in a manner similar to and is intended for the same use as Point 4 Modified that is currently marketed by Kerr Dental Materials Center.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three wavy lines below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032921

Trade/Device Name: Premise Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 15, 2003 Received: September 22, 2003

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Colleen Boswell

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Oup

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):____K032921

Device Name: Premise

Indications For Use:

Premise is a dental composite restorative material intended to be used in all classes of cavites.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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