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510(k) Data Aggregation

    K Number
    K022973
    Device Name
    ADHESIVE 14
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

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

    ADHESIVE 14

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

    ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Adhesive 14. It does not contain any information regarding acceptance criteria or a study demonstrating the device meets those criteria.

    The document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance requirements. It does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
    • Information about MRMC studies, standalone algorithm performance, or ground truth types.
    • Details about training set size or how its ground truth was established.

    Therefore, I cannot fulfill the request using the provided text.

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