EnDrive (EnDriveUS)

EnDrive is a battery-operated electronic handpiece for endodontic (root canal) treatment. It rotates nickel-titanium files continuously or reciprocally with torque control to prepare and clean infected root canals, and includes an integrated apex locator that determines when the file reaches the canal apex using two patient-contact electrodes.

EnDrive uses a brushless DC motor (250-1000 rpm, 0.4-5.0 N·cm torque) powered by internal lithium battery in the handpiece and NiMH battery in the control unit, connecting via Bluetooth. It features a touchscreen interface, three operating modes (motor, apex locator, multifunction), and supports software updates via Wi-Fi. Minor differences from the predicate include slightly different power specifications, charging method (cable vs. wireless), and performance ranges that overlap clinically.

ISO 10993-1, 10993-5, 10993-18 (biocompatibility); ISO 10993-23, ISO 14457, ISO 17665, ISO 17664 (device-specific); IEC 60601-1, 60601-1-2, 62133-2 (electrical and safety); EMC and reprocessing testing per relevant standards.

EnDrive and the predicate (C-SMART-I Pilot, K220829) share identical intended use as motorized endodontic handpieces with integrated apex locator for root canal preparation and length measurement in dental settings. Both use cordless batteries, support continuous rotation and reciprocating modes, achieve equivalent apex locator accuracy (±0.5 mm), employ the same NiTi file technology, and use identical sterilizable accessories. Performance ranges overlap substantially (250-1000 rpm vs. 150-1000 rpm; torque ranges ensure equivalent clinical performance). Bench testing confirmed substantially equivalent motor speed, torque, and apex locator accuracy. Minor differences in battery voltage, user interface, physical dimensions, and charging method do not raise new safety or effectiveness concerns and have been verified through design validation.