(56 days)
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.
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a dental composite material, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the FDA's decision regarding its market clearance. It does not include details about specific performance studies or acceptance criteria that would typically be found in a clinical trial report or a detailed performance testing document.
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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 (714) 516-7602 - Phone (714) 516-7472 - 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.