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510(k) Data Aggregation

    K Number
    K222548
    Device Name
    Endo Motor
    Manufacturer
    Shenzhen Perfect Medical Instruments Co., Ltd.
    Date Cleared
    2023-04-26

    (246 days)

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

    Shenzhen Perfect Medical Instruments Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
    Device Description
    The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
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