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510(k) Data Aggregation

    K Number
    K121880
    Device Name
    DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2012-09-25

    (89 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    DMRC Nanoflow and DMRC Nanocomposite

    AI/ML Overview

    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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