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    K Number
    K111876
    Device Name
    Z BOND, PRELUDE ONE
    Manufacturer
    DANVILLE MATERIALS, INC.
    Date Cleared
    2011-09-21

    (82 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Z BOND, PRELUDE ONE

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

    Z Bond and Prelude One are a Primer and adhesive used for:

    • Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays.
    • Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition.
    • . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter and "Indications for Use Form" from the FDA concerning dental bonding agents (Z Bond and Prelude One).

    It does not contain information about:

    • Acceptance criteria for a device performance study.
    • Details of a study proving device meets acceptance criteria (experimental design, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

    Therefore, I cannot fulfill your request based on the provided text.

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