ELEC ENGINE (Model: ISE-170L)

The ELEC ENGINE (Model: ISE-170L) is an implant surgical engine designed for dental oral surgery and dental implant procedures. It operates and controls a dental handpiece via a brushless DC (BLDC) motor and foot control, converting AC power to DC power to drive handpieces fitted with cutting tools for hard tissue removal in the mouth.

The device has identical specifications to the predicate (Impla-NX ISE-270M/ISE-270C): maximum motor torque of 70 mNcm, motor speed of 200–40,000 rpm, 6 pre-set implant systems with 9 user-defined steps each, optical feedback, and E-type (ISO 3964) handpiece conformance. Minor design differences include button shape and location, foot switch color, irrigation tube size, maximum coolant flow rate, housing design, and bolt size.

IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60 (electrical and mechanical safety); ISO 17664-1, ISO 17665-1 (reprocessing validation); ISO 10993-1, ISO 10993-5, ISO 10993-23, ISO 10993-10 (biocompatibility); ISO 14457 (performance); IEC 60601-1-6, IEC 62366-1 (usability).

The device shares identical intended use, indications, and functional specifications with the predicate device across all critical parameters (torque, speed, memory, shank conformance, package contents). The observable differences (button shape, switch color, tube size, housing, bolts) are cosmetic or minor manufacturing variations that do not introduce new safety or effectiveness risks, and the device passed all required performance and biocompatibility testing per applicable standards.