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510(k) Data Aggregation

    K Number
    K111465
    Device Name
    COMPOTHIXO
    Manufacturer
    Date Cleared
    2012-07-25

    (426 days)

    Product Code
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERRHAWE SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Compothixo is a vibration instrument intended for composite modeling by dental professionals.
    Device Description
    Compothixo is a hand-held, battery-operated, vibration composite modeling instrument. When the device is turned on the unit begins to vibrate at 140 Hz. It functions in the same way as a hand-operated composite modeling instrument, and also has interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW. Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status. The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.
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