PREMISE MODIFIED

K090292 · Kerr Corp. · EBF · Apr 3, 2009 · Dental

Device Facts

• Record ID: K090292
• Device Name: PREMISE MODIFIED
• Applicant: Kerr Corp.
• Product Code: EBF · Dental
• Decision Date: Apr 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Premise Modified is a light-cured, resin-based composite dental restorative material. It is designed for direct placement by dental professionals in a clinical setting to restore all classes of cavities. The device utilizes a three-filler system to achieve high polishability, increased mechanical strength, and reduced polymerization shrinkage compared to traditional composites. The material is applied directly into the cavity preparation by the clinician and cured using a dental light source. The resulting restoration provides structural support and aesthetic replacement for missing tooth structure, benefiting the patient by restoring tooth function and appearance.

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. Utilizes a three-filler system to optimize mechanical properties and polymerization shrinkage. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for use in all classes of dental cavities for patients requiring restorative dental procedures.

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

• Premise (K040921)

Submission Summary (Full Text)

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K090292

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.

APR - 3 2009

### 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 Colleen Boswell - Contact Person

Date Summary Prepared: February 2009

#### Device Name:

- Trade Name - Premise Modified
- . 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, Premise
#### Device Description:

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

#### Intended Use of the Device:

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

## Substantial Equivalence:

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Kerr Corporation C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

APR - 3 2009

K090292 Re:

> Trade/Device Name: Premise Modified Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 23, 2009 Received: March 25, 2009

Dear Ms. Garman:

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. Garman

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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Susan Runner

Ginette Y. Michaud, M.D. Acting 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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K090292

# Indications for Use

510(k) Number (if known):

Device Name: Premise Modified

Indications For Use:

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

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 Purver

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

510(k) Number: K040921

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