Dental Implant Unit

The Dental Implant Unit is a mechanical drive unit with coolant supply used in dental surgery, implantology, and maxillofacial surgery for treatment of dental hard tissue. It comprises a main control unit, motor with tube, handpiece, foot pedal, and holder, offering eight programmable modes including positioning, hole-drilling, hole-broadening, tapping, implanting, abutment screw locking, user-defined mode, and cleaning.

The proposed device differs from the predicate in three key ways: (1) slightly larger dimensions (286×252×113 mm vs. 276×267×110 mm for the control unit); (2) higher maximum mechanical output power (150W vs. 120W); and (3) lower starting motor speed range (200–40,000 rpm vs. 300–40,000 rpm). Both maintain the same torque (5.5 Ncm), irrigation rate (110 ml/min), 8 programs, capacitive touch display, and ISO 3964 coupling compatibility.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 80601-2-60 (applied parts), IEC 62304 (software validation), ISO 10993-1 (biocompatibility), and general sterilization, shelf-life, and packaging testing.

The proposed device is substantially equivalent because the dimensional differences do not affect usability or safety as demonstrated by passing all electrical safety and usability compliance tests. The increased power (150W vs. 120W) provides improved performance for harder tissues without altering fundamental operation. The expanded lower speed range (200 rpm start vs. 300 rpm) enhances precision during delicate procedures while maintaining identical maximum speed (40,000 rpm). All safety and performance tests confirm the device meets predefined acceptance criteria and performs equivalently to the predicate despite these enhancements.