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510(k) Data Aggregation

    K Number
    K210789
    Device Name
    EQ-PEX
    Manufacturer
    Meta Systems Co., Ltd.
    Date Cleared
    2021-10-20

    (218 days)

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

    Meta Systems Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
    Device Description
    EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord. The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
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    K Number
    K153285
    Device Name
    EMS-200
    Manufacturer
    META SYSTEMS CO., LTD.
    Date Cleared
    2016-08-12

    (274 days)

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

    META SYSTEMS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.
    Device Description
    The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.
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