Integral Dental Units

The Integral Dental Units are dental treatment units designed to supply power and serve as a base for dental devices and accessories in clinical/office environments. They consist of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong and weak suction, cuspidor, x-ray film viewer, and foot pedal, used by trained dentists, technicians, and assistants.

The device features LED operating lights (8 white LEDs with switchable yellow capability), AC 24V power connection to the light, a water heater with heating coil maintaining 33–35°C, ISO 9168-compliant connection joints, control panels with foot controller, and dental chair specifications including 150 kg loading capacity and movement range of 380–780 mm with 2°–67° backrest angular movement.

IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62366-1, IEC 62304, ISO 10993-1, ISO 7494-1:2018, ISO 7494-2:2022, ISO 9680:2021, ISO 9168, and ISO 10993-5/10/23 for biocompatibility testing.

The subject device shares the same intended use, classification (Class I, EIA product code, 21 CFR 872.6640), and core functional features as predicate devices K231845 and K233921. Differences in power supply range (110V–240V vs. 110V only), chair movement ranges, and saliva ejector suction rate (>400 mL/min vs. >750 mL/min) do not affect safety and effectiveness because the device demonstrates compliance with all applicable electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60) and performance standards (ISO 7494-1/2), ensuring these variations introduce no additional hazards.