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510(k) Data Aggregation

    K Number
    K080478
    Device Name
    GRADIA FORTE
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2008-06-05

    (104 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GRADIA FORTE is intended to be used for the indirect restoration of crown & bridge, inlays, veneers and implant superstructures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment for the GRADIA FORTE device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a legally marketed predicate device for its indicated uses. It does not contain the kind of detailed study breakdown you've requested.

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