Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

The Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) is a cordless, battery-powered endodontic handpiece used by dental professionals to prepare and enlarge root canals, measure canal length, and monitor file position during treatment. It features an LCD display, adjustable speed and torque settings, and can save nine customized programs.

The proposed devices use brushless motors powered by lithium batteries (DC3.7V), have adjustable torque (0.6–4.0 N·cm range depending on model) and rotational speeds (120–1200 rpm), include USB ports, and feature auto-reverse and auto-stop functions. They differ from the predicate in dimensions, weight, torque ranges, rotational speed ranges, and gear ratios, but remain within clinically acceptable operating parameters.

ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62366-1 (usability engineering), IEC 62304 (software), and IEC 80601-2-60 (dental handpiece requirements). Testing also included reprocessing validation (cleaning, disinfection, sterilization) and functional testing.

The proposed device shares the same fundamental intended use, design approach, and clinical application as the predicate (root canal preparation and measurement). Although dimensions, weight, torque range, speed range, and gear ratio differ, all differences are either within clinically acceptable operating parameters or explicitly tested and validated. The device incorporates identical safety mechanisms (auto-reverse/stop at apical stop), identical components, and passes all applicable safety and performance standards. No new safety or effectiveness concerns are introduced by these minor design variations.