NANOCERAM- BRIGHT

K102257 · Dmp, Ltd. · EBF · Nov 19, 2010 · Dental

Device Facts

• Record ID: K102257
• Device Name: NANOCERAM- BRIGHT
• Applicant: Dmp, Ltd.
• Product Code: EBF · Dental
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anterior restorations (Class III, IV) · Posterior restorations (Class I, II) · Class V restorations (Cervical caries, root erosion, wedge shaped defects) · Veneering of discolored anterior teeth · Splinting of mobile teeth · Repair of composite and ceramic veneers

Device Story

NANOCERAM-BRIGHT is a dental restorative material used by dentists for direct restorations. It functions as a composite resin for filling cavities, repairing defects, and splinting teeth. Applied by clinicians in a dental office setting, the material is placed into prepared tooth cavities or onto tooth surfaces to restore form and function. It hardens to provide structural support and aesthetic correction for damaged or discolored teeth.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental composite resin material. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for dental patients requiring anterior (Class III, IV) or posterior (Class I, II) restorations, Class V restorations (cervical caries, root erosion, wedge defects), veneering of discolored anterior teeth, splinting of mobile teeth, and repair of composite or ceramic veneers.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Dimitris Prantsidis Director DMP Limited Kalyvion Avenue, Markopoulo Industrial Markopoulo, Attiki Greece 19003

NQV 1. 9 2010

Re: K102257

Trade/Device Name: NANOCERAM-BRIGHT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth and Resin Material Regulatory Class: II Product Code: EBF Dated: October 19, 2010 Received: October 27, 2010

Dear Mr. Prantsidis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Prantsidis

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S. M.S., M.B.A. 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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K102257

## SECTION: Indications for Use Statement 4.

Device name: NANOCERAM - BRIGHT

Indications for use:

- · Anterior restorations (Class III, IV)
- · Posterior restorations (Class I, II)
- · Class V restorations (Cervical caries, root erosion, wedge shaped defects)
- · Veneering of discolored anterior teeth
- · Splinting of mobile teeth . : .
- · Repair of composite and ceramic veneers

NOV 1 9 2010

.

Susan Runne

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

510(k) Number: K102257