Motor Handpiece and Control Unit (SDI10)

The SDI10 is a motorized dental handpiece control unit consisting of a control unit, micro-motor, and AC/DC adapter. It is intended for use in dentistry for restoration, prophylaxis, and endodontic procedures by converting pneumatic output from a dental treatment center to control motorized dental handpieces.

The SDI10 features a brushless motor with internal coolant air, DC 40V power supply, speed range of 2,000–40,000 rpm, maximum torque of 3 Ncm, LED optic attachment, irrigation system, clockwise/counterclockwise rotation, 2.5 bar spray air pressure, and 2 bar spray water pressure. The main difference from the predicate is the DC 40V power supply versus the predicate's AC 24V.

Testing standards include IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 80601-2-60, ISO 14457, ISO 17665-1, ISO 17664-1, ISO 17664-2, and ISO 10993 series (biocompatibility). Cleaning, sterilization, and electromagnetic compatibility testing were also conducted per FDA guidance documents.

The SDI10 is substantially equivalent to the predicate device (ELEC-LED, K201191) because both share the same indications for use, identical motor type, device components, speed capability, maximum torque, rotation direction, spray pressures, and ISO 3964 shank compliance. The difference in power supply voltage (DC 40V vs AC 24V) does not raise different safety or effectiveness questions, as demonstrated by appropriate safety and performance testing per IEC standards.