# K251389: High speed air turbine handpiece

- 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: 9 generations back to K935676 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170229: Dental High-speed Turbine Handpiece, Guangdong Jinme Medical Technology Co., Ltd. (2017) Summary page 5.

## Indications for use
High-speed air turbine 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/K251389
Methodology: https://510kreport.com/methodology