# K251388: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Topmed Dental Co., Ltd.
- Decided: Jan 12, 2026 after 252 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935676 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170236: Dental Low-speed Turbine Handpiece, Guangdong Jinme Medical Technology Co., Ltd. (2017) Summary page 5.
- K150798: Codent Low Speed Dental Handpieces and Accessories, Codent Technical Industry Co., Ltd. (2015) Summary page 6.
- K141886: MDK Handpieces, Modern Korea Co., Ltd. (2015) Summary page 6.

## Indications for use
Dental air motor handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Source page: https://510kreport.com/device/K251388
Methodology: https://510kreport.com/methodology