# K181691: High-speed air turbine handpiece / Low-speed air turbine handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Wenjian Medical Instrument Co., Ltd.
- Decided: May 26, 2020 after 699 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). 33 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 36 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 4.
- K170236: Dental Low-speed Turbine Handpiece, Guangdong Jinme Medical Technology Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K220179: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (2023), 1 descendant of its own
- K241074: High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces:  SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces:  SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (2024), 0 descendants of its own

## Indications for use
Dental High-speed Turbine Handpiece (WJ-114, WJ-112, WJ-124, W] -122, WJ-134, W] -132, W] -144, W] -142, W] -154, W1 -152, W1 -164, W] -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-412, WJ]-424, WJ]-422) 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/K181691
Methodology: https://510kreport.com/methodology