# K112623: Airlight Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Beyes Dental Canada, Inc.
- Decided: Dec 16, 2011 after 99 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: 6 generations back to K935676 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052822: Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202, Thunder Tiger Corp. (2006) Summary page 2.
- K062812: Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N, Thunder Tiger Corp. (2006) Summary page 2.
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU, Jindell Medical Instruments Co., Ltd. (2006) Summary page 2.
- K093084: Rolence Dental High Speed Handpiece, RHP, Rolence Ent., Inc. (2009) Summary page 2.
- K063110: CST61 High Speed Turbine Handpiece, Shanghai Dental Instrument Factory (2006) Summary page 2.
- K021250: MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head), Handpiece Unlimited (2002) Summary page 2.
- K101551: Pacemaker High-Speed Handpiece Model PM-MQ, PM-M, Delma Medical Instrument (Guangzhou) Co., Ltd. (2010) Summary page 2.

## Indications for use
Airlight Dental Handpiece Series, models M600 and M8OO are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Source page: https://510kreport.com/device/K112623
Methodology: https://510kreport.com/methodology