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    K Number
    K042759
    Device Name
    OPTIMA MX
    Manufacturer
    BIEN-AIR SA SWITZERLAND
    Date Cleared
    2004-10-20

    (15 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIEN-AIR SA SWITZERLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
    Device Description
    The Optima MX dental unit for use in dental restoration, phophylaxis and endodontic procedures. The Optima MX is composed of a power supply, control unit, hose and a brushless micromotor. The control unit is a programmable unit that controls the torque, speed and clockwise or counterclockwise rotation of the motor. The inputs to the control unit are supplied by a color touchscreen on the Optima MX. Inputs can also be made by the foot pedal of the treatment center through the pneumatic outlet. The micromotor is a brushless motor with 4 quadrant speed control. The micromotor has a rotation speed of 100 - 40,000 rpm and can be rotated in a clockwise or counterclockwise direction.
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