(89 days)
DMRC Nanoflow and DMRC Nanocomposite are designed for use in all classes of cavities. DMRC Nanoflow is a low viscosity composite and DMRC Nanocomposite is a universal viscosity composite.
DMRC Nanoflow and DMRC Nanocomposite
The provided FDA 510(k) document for DMRC NanoFlow and DMRC NanoComposite is primarily a clearance letter, confirming the substantial equivalence of the device to existing products. It does not contain the detailed study information or acceptance criteria typical for a device's performance evaluation as envisioned by the provided prompt.
Therefore, I cannot extract the required information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment directly from the text provided.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices for the indicated uses. The indications for use are: "DMRC Nanoflow and DMRC Nanocomposite are intended to be used in all classes of cavities." It further describes DMRC Nanoflow as a "low viscosity composite" and DMRC Nanocomposite as having "cannot viseosity" (likely a typo, perhaps meaning "nano-viscosity" or similar, or referring to a non-low viscosity).
Therefore, I cannot fulfill the request to complete the table and answer the specific questions about the study design and acceptance criteria based on this document.
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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 (800) 638-2041 or (301) 796-7100 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:
§ 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.