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510(k) Data Aggregation

    K Number
    K063495
    Device Name
    C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
    Manufacturer
    BIOMATERIALS KOREA INC.
    Date Cleared
    2007-07-26

    (248 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K161335,K202691,K222245
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The C Type, CT Type and Special Type Orthodontic Anchor Screws are intended for use as a temporary anchor for orthodontic treatment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for dental implants. It does not contain any information about acceptance criteria, study details, or device performance metrics.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

    The document only states that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to be marketed. It does not include any performance data or a study description.

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