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510(k) Data Aggregation

    K Number
    K101054
    Device Name
    ROMIAPEX MODEL A-15
    Manufacturer
    Date Cleared
    2010-09-03

    (141 days)

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

    ROMIDAN LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
    Device Description
    - The RomiApex™ A-15 is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth. - The RomiApex™ A-15 operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal. - The measurements in RomiAPEX™ A-15 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated rather then mixed, as it is done in other apex locators, thus canceling the need for signal filtering and eliminating the noise caused by non-ideal filters. - The device consists of a main body incorporating the LCD display, a lip Clip, a file clip a cable and a touch prob. - The device is powered by one 1.5 AAA Alkaline battery.
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