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    K Number
    K061252
    Device Name
    PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
    Manufacturer
    PRIMUS CONSULTING
    Date Cleared
    2007-02-12

    (284 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMUS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in bonding orthodontic appliances for orthodontic treatment
    Device Description
    The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.
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