(89 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the material properties and intended use of dental composites.
No
The device, DMRC Nanoflow and DMRC Nanocomposite, are composites for filling cavities, which are restorative rather than therapeutic.
No
The device, DMRC Nanoflow and DMRC Nanocomposite, are composites designed for filling cavities, which are therapeutic materials rather than diagnostic tools.
No
The device description clearly identifies the devices as "DMRC Nanoflow and DMRC Nanocomposite," which are described as composites (materials) used in dental cavities. This indicates a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for filling cavities in teeth. This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description refers to "Nanoflow" and "Nanocomposite," which are terms typically associated with dental filling materials.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the DMRC Nanoflow and DMRC Nanocomposite are dental restorative materials, not in vitro diagnostic devices.
N/A
Intended Use / Indications 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
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three thick, curved lines that suggest the bird's wings and body.
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.
1
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
2
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 (
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Anover
ign-Om)
Anesthesiology, General Hos ontrol, Dental Devices
510(k) Number: