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    K Number
    K222096
    Device Name
    Endo Ultrasonic Activator
    Manufacturer
    Foshan COXO Medical Instrument Co.,Ltd.
    Date Cleared
    2023-03-23

    (248 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foshan COXO Medical Instrument Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
    Device Description
    The Endo Ultrasonic Activator is mainly used for root canal cleaning.It mainly contain handpiece, sleeve, wrench, adapter and tip. The ultrasonic frequency generated by the CPU is driven by the drive circuit to drive the piezoelectric ceramic transducer, using the reverse piezoelectric effect to produce the ultrasonic vibration, motivating the working tip to produce the resonance, and using the cavitation and sound flow effect generated by the ultrasonic vibration to wash the root canal swing.
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