Integral Dental Unit

The Integral Dental Unit (Model YD-A4) is a dental operative unit that supplies power to and serves as a base for dental devices and accessories in professional dental clinic environments. It includes an electronically-operated dental chair, integrated control unit for electricity/water/air supply, instrument tray, dental light, saliva aspirator, three-way syringe, film viewer, and foot switch. The device is designed for use by trained dental professionals and assistants.

The subject device operates on AC 230V, 50/60Hz with compressed air and water supply, has a maximum patient load of 135 kg, chair height range of 450–730 mm (±10 mm), air pressure 0.6–0.80 MPa, water pressure 0.20–0.40 MPa, and uses pneumatically controlled valves with foot pedal control. Compared to predicate K3, the subject device has similar power specifications and main functional components but with slightly different voltage input ranges and dimensional tolerances, which are not considered clinically significant.

IEC 60601-1:2012 (electrical safety), IEC 80601-2-60:2019 (dental equipment requirements), IEC 60601-1-2:2014 (electromagnetic compatibility), ISO 10993-1:2018 (biocompatibility), IEC 62304:2006+AMD1:2015 (software life cycle), ISO 7494-1:2018 and ISO 7494-2:2018 (dental unit performance requirements). FDA guidance on software verification and validation was also applied.

The subject device is substantially equivalent to predicate K3 because both share identical intended use (power supply and base for dental devices in professional clinic settings), same product code (EIA), same regulation class (I), same prescription use designation, and functionally equivalent main components including hydraulic motor-driven chair, pneumatic water/air controls, and three-way syringe. Minor differences in voltage input range (230V vs 100–240V) and chair height specifications (450–730 mm vs 365–795 mm) represent insignificant design variations that do not affect safety or effectiveness, and both comply with identical electrical safety and electromagnetic compatibility standards.