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510(k) Data Aggregation

    K Number
    K053235
    Device Name
    NSK PRECISION APEX LOCATOR (PAL)
    Manufacturer
    Date Cleared
    2006-01-24

    (67 days)

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

    MEDICSENSE U.S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NSK Precision Apex Locator is intended for the measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
    Device Description
    The NSK Precision Apex Locator is a dental medical device which has the ability to measure the depth of the root canal by electronic means.
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