# K240337: Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Jinme Medical Technology Co., Ltd.
- Decided: Nov 13, 2024 after 282 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: 1 generation back to K182999 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182999: General Cutting Contra Handpiece, Nakanishi, Inc. (2019) Summary page 5.

## Indications for use
For Model J6-126, J6-136: The Dental 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. For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L: The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

Source page: https://510kreport.com/device/K240337
Methodology: https://510kreport.com/methodology