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510(k) Data Aggregation

    K Number
    K984044
    Device Name
    QUADRANT POSTERIOR DENSE
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    1998-12-16

    (33 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

    Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound dental tissue. Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.

    Device Description

    light curing dental composite filling material

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental filling material. It does not contain any information about acceptance criteria, device performance, a study, or any of the other details requested in your prompt regarding artificial intelligence or medical imaging devices. Therefore, I cannot fulfill your request based on the given input.

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