(257 days)
The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.
Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip. The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.
The provided text does not contain detailed information about the acceptance criteria or an analytical study proving the device meets those criteria. The 510(k) summary focuses on the device's operating principles and its substantial equivalence to a predicate device, rather than a performance study with specific metrics.
Therefore, I cannot provide the requested information in the format specified. The document primarily describes the administrative aspects of the 510(k) submission, not the technical performance evaluation.
N/A