DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID

K121880 · Danville Materials, Inc. · EBF · Sep 25, 2012 · Dental

Device Facts

• Record ID: K121880
• Device Name: DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
• Applicant: Danville Materials, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DMRC Nanoflow and DMRC Nanocomposite are dental composites. Designed for use in all classes of cavities. DMRC Nanoflow is a low viscosity composite and DMRC Nanocomposite is a high viscosity composite.

Device Story

DMRC Nanoflow and DMRC Nanocomposite are light-cured dental restorative materials. DMRC Nanoflow features low viscosity for flowable applications; DMRC Nanocomposite features high viscosity for standard restorative placement. Used by dental professionals in clinical settings to fill and restore tooth structure in all cavity classes. Materials are applied to the cavity preparation and cured using a dental light-curing unit. The output is a hardened, tooth-colored resin restoration that replaces lost tooth structure, providing functional and aesthetic benefits to the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured resin-based dental composites. Available in two viscosities: low (Nanoflow) and high (Nanocomposite). Intended for direct placement in dental cavities. Class II device per 21 CFR 872.3690.

Indications for Use

Indicated for use in all classes of dental cavities for restorative procedures. Prescription use only.

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

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

SEP 2 5 2012

Ms. Lindsay Tilton Regulatory Affairs Danville Materials, Incorporated 3420 Fostoria Way, Suite, A-200 San Ramon, CA 94583

Re: K121880

Trade/Device Names: DMRC NanoFlow and DMRC NanoComposite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: August 27, 2012 Received: August 31, 2012

Dear Ms. Tilton:

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 - Ms. Tilton

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.

hn 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): K1/2/880

Device Name: DMRC Nanoflow and DMRC Nanocomposit dications For Use:
DM RC Nanoflow and DMRC Nanocolonial contact Commonsistes Indications For Use:

Namalow and and dental composites. light boarder, estimatis placement. These Designed for course intended to be used all classes of canties . DMRC Nandform a low viscosity composite and DMA South western of cannot vise osity

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Us (21 CFR 801 Subpart (

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Anover

ign-Om)
Anesthesiology, General Hos ontrol, Dental Devices

**510(k) Number:**