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510(k) Data Aggregation

    K Number
    K133178
    Device Name
    LUXATOR LX HANDPIECE
    Manufacturer
    DIRECTA AB
    Date Cleared
    2015-11-24

    (768 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    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 designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria of a medical device's performance, nor does it describe a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental handpiece, Luxator LX.

    It primarily discusses:

    • The FDA's determination of substantial equivalence for the device.
    • General regulatory requirements for marketing the device.
    • Contact information for FDA resources.
    • The indications for use of the Luxator LX handpiece.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods based on the given text.

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