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510(k) Data Aggregation

    K Number
    K213897
    Device Name
    Pro M Class
    Manufacturer
    Saeyang Microtech Co., Ltd.
    Date Cleared
    2022-09-19

    (279 days)

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

    Saeyang Microtech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
    Device Description
    The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
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