Apex Locator

The Apex Locator is a dental device used to detect the apex (tip) of a root canal during endodontic procedures. It features an LCD color display with buttons for adjusting settings like sound level, brightness, and reference position. The device is powered by a rechargeable lithium battery and must be used by qualified dental personnel in hospital, clinic, or dental office environments.

The proposed device comes in two models (APEX-S and APEX-R) with different dimensions and weights compared to the predicate. It uses button control input (versus the predicate's touch screen and foldable design), has a smaller battery capacity (800mAh vs. 1800mAh), and slightly different cable lengths. Both devices maintain the same measurement accuracy of ±0.5mm and use identical components (measuring wire, file clip, lip hook, touch probe, tester).

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability engineering), IEC 62304 (software), ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 (biocompatibility), and IEC 62133-2 (battery safety).

The device is substantially equivalent because it performs the same intended function as the predicate (root apex detection) with identical measurement accuracy and the same anatomical application. Seven identified differences—including dimensions, weight, battery capacity, cable length, input means, reference color marking, and material specifications—do not affect safety or effectiveness. All differences are characterized as cosmetic or ergonomic in nature, and the device demonstrates compliance with the same safety and performance standards as the predicate through biocompatibility, software validation, electromagnetic compatibility, electrical safety, and functional testing.