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    K Number
    K984042
    Device Name
    QUADRANT CORE LC
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    1998-12-04

    (21 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K041323
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Quadrant Core LC is a light curing dental composite filling material used in the adhesive restorative technique.

    Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.

    Quadrant Core LC is especially designed for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

    Device Description

    Quadrant Core LC is a light curing dental composite filling material.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental composite filling material, "Quadrant Core LC," indicating that the device has been found substantially equivalent to a legally marketed predicate device. It does not contain any details about studies or data that would address your specific questions regarding acceptance criteria and device performance evaluation.

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