Apex Locator (FindPex)

The Apex Locator (FindPex) is a dental device that detects the apex of root canals by measuring electrical impedance of dental tissue. It consists of a main unit, base, touch probe, file clip, lip hook, measuring wire, adapter, and tester. The device is used by qualified dental personnel in hospital, clinic, or dental office environments for prescription use only.

The FindPex uses a 3.5-inch color TFT display with IPS technology (versus the predicate's 4.5-inch LCD), operates at 500Hz and 8kHz measurement frequencies (versus predicate's 400Hz and 8kHz), has a measuring voltage of 30mVAC nominal, weighs 250.9g (versus predicate's 385g), and features three push buttons with adjustable auto power-off (5–15 minutes). Both devices use rechargeable 3.7V lithium batteries and the same impedance ratio calculation method.

IEC 60601-1-2:2020, IEC TR 60601-4-2:2016, IEC 80601-2-60:2019, IEC 60601-1:2020, ANSI AAMI ES60601-1:2005/(R)2012, ISO 10993-1 (biocompatibility), ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 7405:2018 (dental biocompatibility), and IEC 62304:2006+A1:2015 (software lifecycle).

The subject device is substantially equivalent to the predicate Apex Locator DPEX III because both have identical indications for use (detecting root canal apex), use the same operating principle (impedance ratio measurement), share the same product code (LQY) and regulatory classification (unclassified), and comparative performance testing demonstrated equivalent root canal length measurement accuracy. Non-clinical testing including biocompatibility, electrical safety, electromagnetic compatibility, and software validation all confirmed safety and effectiveness equivalent to the predicate.