High speed air turbine handpiece

A high-speed air turbine handpiece is a dental instrument composed of a head, handle, and connector used by dental professionals for drilling, grinding, and repairing teeth. It is intended for removing carious material, cavity and crown preparation, finishing tooth preparations, root canal preparation, and polishing teeth.

The proposed device is air-powered with single/triple water spray and push-button chuck operation, operating at 300,000–400,000 rpm. It differs from the predicate in material composition (stainless steel and brass vs. stainless steel, brass, and titanium), bur extraction force (≥22N vs. 28N), and operating pressure (0.20–0.25 MPa vs. 177–301 kPa), but both use steam autoclave sterilization and the same specified lubricant.

ISO 14457:2017 (Dentistry—Handpieces and Motors) for performance; ISO 10993-1:2018, ISO 10993-5:2019, ISO 10993-10:2021, ISO 10993-11:2017, and ISO 10993-23:2021 for biocompatibility (cytotoxicity, skin sensitization, systemic toxicity, and irritation).

The subject device has all essential features of the predicate (K170229). Although material composition, bur extraction force, and operating pressure differ, both devices conform to ISO 14457:2017 and demonstrate equivalent safety and performance. Biocompatibility testing confirms the different material composition poses no safety concern, and all differences were evaluated as not affecting safety or effectiveness compared to the predicate.