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510(k) Data Aggregation

    K Number
    K202075
    Device Name
    Dental Electric Motor
    Manufacturer
    Foshan CICADA Dental Instrument Co, Ltd.
    Date Cleared
    2022-03-11

    (592 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foshan CICADA Dental Instrument Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm. The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction. The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center. The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
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