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    K Number
    K123695
    Device Name
    TRAUS SIP10
    Manufacturer
    SAESHIN PRECISION CO., LTD.
    Date Cleared
    2012-12-18

    (15 days)

    Product Code
    EKY
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
    Device Description
    The TRAUS SIP10 is an AC-powered device that includes a hand-held motor, controller, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.
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