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    K Number
    K042806
    Device Name
    QUADRANT UNIT-1-BOND
    Manufacturer
    CAVEX HOLLAND B.V.
    Date Cleared
    2004-11-24

    (43 days)

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

    QUADRANT UNIT-1-BOND

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

    Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.

    Device Description

    Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Quadrant Uni-1-Bond. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot extract the requested information from the provided text.

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