BRILLIANT EVERGLOW by COLTENE/WHALEDENT AG

This document is a 510(k) clearance letter from the FDA for a dental material called BRILLIANT EverGlow. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The information provided describes:

The FDA's decision that the BRILLIANT EverGlow material is "substantially equivalent" to legally marketed predicate devices.
The regulation number and name for the material (21 CFR 872.3690, Tooth shade resin material).
The intended uses for the BRILLIANT EverGlow material, which are direct filling of various classes of cavities, as well as cementation and repair of composite and ceramic restorations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets acceptance criteria based on the provided text, as it concerns a dental material's substantial equivalence to existing products, not a device study with the requested metrics.

Summary

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

April 28, 2016

Coltene/Whaledet AG Mr. Silke Wallaschek Head Regulatory Affairs Feldwiesenstr. 20 Altstätten, St. Gallen 9450 SWITERLAND

Re: K152927

Trade/Device Name: BRILLIANT EverGlow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: March 23, 2016 Received: April 1, 2016

Dear Mr. Wallaschek:

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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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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name:

BRILLIANT EverGlow

Indications for Use:

BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for:

Direct filling of class I, II, III, IV and V cavities
Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for:

Shape and color corrections to enhance the individual esthetics
Reconstruction of incisal edges
Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Altstätten Switzerland Phone +41 (0)71 757 53 00 Fax +41(0)71 757 53 10 e-mail : info.ch@coltene.com

Regulation Number and Section

§ 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.