BRIGHT RESTORATIVE MATERIALS

K121915 · Dmp, Ltd. · EBF · Sep 28, 2012 · Dental

Device Facts

• Record ID: K121915
• Device Name: BRIGHT RESTORATIVE MATERIALS
• Applicant: Dmp, Ltd.
• Product Code: EBF · Dental
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NANOCERAM - BRIGHT FLOW Indications for use: Fillings of minimally invasive cavities of all classes Fillings of small class I cavities Fillings of class II-V cavities including V-shaped defects and cervical caries Extended fissure sealing Cavity lining as the first layer for Class I and II restorations Splinting of mobile teeth Blocking out of undercuts Small restorations of all types Repair of composite restorations and ceramic veneers BRIGHT FLOW CORE - BRIGHT HEAVY CORE Indications for use: Core build up of vital and non-vital teeth Post cementation BRIGHT LIGHT - BRIGHT LIGHT FLOW BRIGHT LIGHT Indications for use: Class I-V restorations Reconstruction of affected anterior teeth Veneering of discoloured anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers BRIGHT LIGHT FLOW Indications for use: Fillings of minimally invasive cavities of all classes Fillings of class II-V cavities including V-shaped defects and cervical caries Extended fissure sealing Splinting of mobile teeth Blocking out of undercuts Small restorations of all types Repair of composite restorations and ceramic veneers BRIGHT POSTERIOR Indications for use: Direct posterior restorations (Class I and II), including occlusal surfaces Core build ups Splinting of mobile teeth

Device Story

Bright Restorative Materials are light-cured, resin-based dental restorative composites. Used by dentists in clinical settings for direct restorations, core build-ups, and cavity lining. Materials are applied to prepared tooth cavities or surfaces and cured using a dental curing light. Output is a hardened, tooth-colored restorative material that replaces lost tooth structure or reinforces tooth integrity. Benefits include restoration of function and aesthetics for patients with dental caries, defects, or structural loss.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, resin-based dental restorative materials. Formulated as flowable or packable composites for various restorative applications. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for dental patients requiring restorative procedures including Class I-V cavity fillings, core build-ups, fissure sealing, splinting of mobile teeth, blocking undercuts, and repair of composite/ceramic veneers. Applicable to vital and non-vital teeth.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Konstantinos Kyritsis, PH.D. Research and Development Manager DMP. Limited Kalyvion Avenue Markopoulo Industrial Zone Attiki, 19003 GREECE

Re: K121915

Trade/Device Name: Bright Restorative Materials (Nanocream-Bright Flow, Bright Flow Core, Bright Heavy Core, Bright Light, Bright Light Flow, and Bright Posterior

Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC Dated: May 28, 2012 Received: July 2, 2012

Dear Dr. Kyritsis:

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.

SEP 2 8 2012

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Page 2 - Dr. Kyritsis

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.

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 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,

Ph 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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# Indications for Use

#### 510(k) Number (if known): K121915

Device Name: BRIGHT Restorative Materials, to include:

- NANOCERAM BRIGHT FLOW .
- BRIGHT FLOW CORE .
- BRIGHT HEAVY CORE .
- BRIGHT LIGHT .
- BRIGHT LIGHT FLOW .
- · BRIGHT POSTERIOR

### Indications for Use:

# NANOCERAM - BRIGHT FLOW

Indications for use:

- · Fillings of minimally invasive cavities of all classes
- Fillings of small class I cavities .
- Fillings of class II-V cavities including V-shaped defects and cervical caries
- Extended fissure sealing �
- Cavity lining as the first layer for Class I and II restorations
- Splinting of mobile teeth ●
- Blocking out of undercuts
- Small restorations of all types
- Repair of composite restorations and ceramic veneers

## BRIGHT FLOW CORE - BRIGHT HEAVY CORE

Indications for use:

- Core build up of vital and non-vital teeth .
- Post cementation

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## BRIGHT LIGHT - BRIGHT LIGHT FLOW

# BRIGHT LIGHT

Indications for use:

- Class I-V restorations .
- Reconstruction of affected anterior teeth ●
- Veneering of discoloured anterior teeth .
- Splinting of mobile teeth
- Repair of composite and ceramic veneers

#### BRIGHT LIGHT FLOW

Indications for use:

- · Fillings of minimally invasive cavities of all classes
- Fillings of class II-V cavities including V-shaped defects and cervical caries .
- Extended fissure sealing .
- Splinting of mobile teeth .
- Blocking out of undercuts .
- Small restorations of all types .
- Repair of composite restorations and ceramic veneers

# BRIGHT POSTERIOR

Indications for use:

- · Direct posterior restorations (Class I and II), including occlusal surfaces
- Core build ups ●
- Splinting of mobile teeth

Prescription Use . X (21 CFR Part 801 Subpart D) AND/OR

. Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

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| 510(k) Number: | K121915 |