# K093971: Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: North West Medical Instrument (Group) Co., Ltd.
- Decided: Apr 22, 2010 after 119 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 K760929 (1976). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070155: Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor Int-D and Attachment Int-SNC, Osseo Scientific, LLC (2007) Summary page 3.
- K071561: HI-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D, Beijing North Pole Dental Handpiece Co., Ltd. (2007) Summary page 4.

## Indications for use
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology. This device is an air-powered hand-held device, intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.

Source page: https://510kreport.com/device/K093971
Methodology: https://510kreport.com/methodology