Foshan Topmed Dental Co., Ltd. · Class I · Cleared Jan 12, 2026
| K-number | K251388 |
| Device name | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) |
| Applicant | Foshan Topmed Dental Co., Ltd. |
| Product code | EFB |
| Device class | Class I |
| Decision date | Jan 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.4200 |
The dental air-motor handpiece is an air-powered instrument used by dental professionals for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations, and polishing teeth. It consists of 11 model variations with low-speed air motors, straight handpieces, and geared angle handpieces with various gear ratios.
The device operates at 17,000–24,000 rpm with operating pressure of 0.20–0.30 MPa, features push-button, wrench, screw, and tip-lock chuck options, and is composed of stainless steel and brass. It is sterilizable by steam autoclave and requires the specified lubricant PANA SPRAY Plus by NAKANISHI INC.
ISO 14457:2017 (Dentistry—Handpieces and Motors); ISO 10993-1:2018, ISO 10993-5:2019, ISO 10993-10:2021, ISO 10993-11:2017, and ISO 10993-23:2021 for biocompatibility evaluation of medical devices.
The subject device has the same intended use, operational mode (air-powered), classification, regulation, and sterilization method as three predicate devices. Minor differences in chuck type, material composition, operating pressure, and motor speed do not affect safety and effectiveness, as evidenced by compliance with applicable ISO standards and nonclinical testing demonstrating equivalent performance.
View the full FDA submission: accessdata.fda.gov