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510(k) Data Aggregation

    K Number
    K073185
    Device Name
    APX21
    Manufacturer
    TECHDENT TECHNOLOGIES, LTD.
    Date Cleared
    2008-03-06

    (114 days)

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

    TECHDENT TECHNOLOGIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APX21 is an electronic apparatus intended to estimate the position of an endodontic file in the root canal with respect to the apex point. The APX21 is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
    Device Description
    The APX21 is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
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