BRILLIANT EVERGLOW

K152927 · Coltene/Whaledent AG · EBF · Apr 28, 2016 · Dental

Device Facts

• Record ID: K152927
• Device Name: BRILLIANT EVERGLOW
• Applicant: Coltene/Whaledent AG
• Product Code: EBF · Dental
• Decision Date: Apr 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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)

Device Story

BRILLIANT EverGlow is a light-cured, radiopaque, submicron hybrid composite resin used by dental professionals for restorative procedures. It is applied directly into prepared tooth cavities or used for aesthetic corrections and repairs of existing restorations. The material is placed by the clinician and cured using a dental curing light. It provides a restorative solution for structural tooth repair and aesthetic enhancement. The device is intended for prescription use in a clinical dental setting.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured, submicron hybrid composite resin. Radiopaque. Supplied in various shades including Bleach, Translucent, and standard tooth shades. Designed for direct application and polymerization via dental curing light.

Indications for Use

Indicated for direct filling of class I-V cavities, shape/color correction, incisal edge reconstruction, and cementation/repair of composite and ceramic restorations in patients requiring dental restorative 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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] Fax [phone] e-mail : [e-mail]