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    K Number
    K022972
    Device Name
    MICROFILL 13
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    MICROFILL 13

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

    MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device called "Microfill 13." However, it is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you asked for. The document solely focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing "Microfill 13" to be marketed.

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