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510(k) Data Aggregation

    K Number
    K980864
    Device Name
    POWER COINS GLOW IN THE DARK LIGATURES
    Manufacturer
    ORTHO KINETICS CORP.
    Date Cleared
    1998-04-20

    (46 days)

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

    POWER COINS GLOW IN THE DARK LIGATURES

    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. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Power Coins Glow in the Dark Ligatures." It grants clearance for the device to be marketed. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions. It does not delve into specific performance metrics, clinical studies, or technical evaluations.

    Therefore, I cannot provide the requested table and study details based on the input text.

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