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510(k) Data Aggregation

    K Number
    K090106
    Device Name
    PRELUDE ONE
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2009-03-31

    (89 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

    Device Description

    Prelude One is a dental bonding agent used to restore all classes of cavities

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental bonding agent (Prelude One) and primarily focuses on its substantial equivalence to predicate devices, intended use, and regulatory classification. It does not include details about device performance tests, clinical studies, or specific acceptance criteria.

    Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

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