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510(k) Data Aggregation

    K Number
    K203836
    Device Name
    BOMEDENT Apex locator, WISMY Apex locator
    Manufacturer
    ChangZhou BoMedent Medical Technology Co., Ltd
    Date Cleared
    2021-03-30

    (90 days)

    Product Code
    LQY, LOY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ChangZhou BoMedent Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
    Device Description
    The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)
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    K Number
    K191276
    Device Name
    Dental Electrical Motor iRoot Pro
    Manufacturer
    ChangZhou BoMedent Medical Technology Co., Ltd.
    Date Cleared
    2020-06-30

    (414 days)

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

    ChangZhou BoMedent Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement 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.
    Device Description
    The Dental Electrical Motor iRoot Pro is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by USB interface. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization and calibration. The product also provides a complete rotation mode and root canal measurement mode, which can be stored in memory, and provides a key functional mode for users to use quickly. The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. The Dental Electrical Motor iRoot Pro is intended to be sterilized prior to use. There are four working modes as: Mode: Only endo motor function enabled; Mode: Endo motor and apex locator work independently, when the file reaching theapical, the apex locator only plays the role of warning and display, will not interfere with the rotation of endo motor, the motor will not stop and reverse when the file reach the apical. Mode: In this mode, the motor will automatically rotate, stop, reverse depends on the length of the root canal measured by the apex locator.
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