DMC COMPOSITE

K081695 · Kerr Corp. · EBF · Aug 12, 2008 · Dental

Device Facts

• Record ID: K081695
• Device Name: DMC COMPOSITE
• Applicant: Kerr Corp.
• Product Code: EBF · Dental
• Decision Date: Aug 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations. DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

Device Story

DMC Composite is a light-cure, radiopaque dental resin restorative material containing 82% filler by weight. Offered in high and low viscosity formulations. Used by dentists in clinical settings for direct restorations, core buildups, and various dental repairs. Applied directly to the tooth structure and cured using a dental light-curing unit. Provides structural restoration and aesthetic repair of teeth. Benefits include versatility in caries management and restorative procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cure resin composite; 82% filler by weight; radiopaque; high and low viscosity formulations; Class II device (21 CFR 872.3690).

Indications for Use

Indicated for patients requiring dental restorations, including all caries classes (High Viscosity) or Class I, II, III, and V restorations (Low Viscosity). Also indicated for core buildup, pit/fissure sealing, and repair of porcelain/composite restorations or enamel defects.

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, Kerr Corporation
• Premise Flowable, Kerr Corporation

Submission Summary (Full Text)

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K081695

# SYBRON DENTAL SPECIALTIES

AUG 1 2 2008

# 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 Garman - Contact Person

Date Summary Prepared: June 2008

## Device Name:

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

Devices for Which Substantial Equivalence is Claimed:

- · Premise, Kerr Corporation
- · Premise Flowable, Kerr Corporation

#### Device Description:

DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.

#### Intended Use of the Device:

DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.

DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

#### Substantial Equivalence:

DMC Composite is substantially equivalent to other legally marketed devices in the United States. DMC Composite functions in a manner similar to Premise Flowable, all currently marketed by Kerr Corporation.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 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

AUG 1 2 2008

Re: K081695

Trade/Device Name: DMC Composite Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 13, 2008 Received: June 17, 2008

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,

VAmmuel (Lendris fox//

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

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# Indications for Use

510(k) Number (if known):

Device Name: DMC Composite

Indications For Use:

DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.

DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

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)

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Suver Y Kim Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number: