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    K Number
    K973495
    Device Name
    GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
    Manufacturer
    GLENROE
    Date Cleared
    1997-12-01

    (76 days)

    Product Code
    ECI
    Regulation Number
    872.5410
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLENROE GLOW IN DARK ELASTOMERIC LIGATURES

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

    Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 4 to 6 weeks when they are replaced with new ties.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Mr. John Bozman regarding "Glenroe Glow In Dark Elastomeric Ligatures". This document is a regulatory clearance letter and does not contain any information about acceptance criteria or a study proving device performance.

    Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically found in the scientific documentation or clinical evaluations submitted as part of the 510(k) application, not in the clearance letter itself.

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