turbodent touch

turbodent touch is an air polishing unit intended for supra-gingival and sub-gingival prophylaxis treatment. It removes dental plaque, soft deposits, and surface stains using a jet of compressed air, water, and prophylaxis powder. It is also indicated for non-surgical removal of subgingival plaque in periodontal pockets up to 5 mm after initial periodontal treatment.

turbodent touch is a functionally segmented version of the predicate combi touch device, incorporating exclusively the air polishing functionality. It shares the same main components, materials, and manufacturing processes as the predicate. The device operates on mechanical action of an accelerated powder jet using compressed air, with water spray surrounding the powder jet to prevent powder dissemination.

IEC 60601-1-6:2010, IEC 60601-1:2005, IEC 80601-2-60:2019 (electrical safety); IEC 60601-1-2:2014 (electromagnetic compatibility); ISO 10993-1 (biocompatibility); IEC 62304+A1 (software); ASTM D4169 (distribution/transit simulation).

turbodent touch shares substantially identical intended use and principle of operation with the predicate combi touch. The device is derived from the predicate by removing only the ultrasonic scaling functionality while retaining all air polishing components and characteristics. The identified differences (removal of ultrasonic channel, software modifications, handpiece variations) do not introduce new safety or effectiveness concerns because they represent functional segmentation of an already-cleared device rather than fundamental design changes.