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510(k) Data Aggregation

    K Number
    K980195
    Device Name
    FACEBOW
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-03-11

    (50 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for the prescribed treatment of malocclusions by dentists.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a device called "Facebow" (K980195). This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

    The information you are asking for would typically be found in the 510(k) submission itself, or in supporting documentation, but it is not present in this clearance letter.

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