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510(k) Data Aggregation
K Number
K032743Device Name
APEX NRG
Manufacturer
MEDIC NRG LTD.
Date Cleared
2004-03-15
(193 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDIC NRG LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 Apex NRG 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 Apex NRG 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. Multi frequencies are used to minimize errors that may be introduced by the entrance of conducting materials such as blood into the canal.
The ratio of the impedance values measured in the canal and lip are calculated to provide a measure of the probe tip relative to the apical foramen. The device consists of a main body incorporating the display, a lip hook, a file clasp and an apron clasp. The device is powered by one 200mAH CR2032 battery
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