# K202371: Highspeed Airturbine Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Dongbo Dental Handpiece Co., Ltd.
- Decided: Nov 8, 2021 after 446 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: 7 generations back to K935676 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141576: Maxima PRO 45L, Kavo DO Brasil Industria E Comercio Ltda (2015) Summary page 5.

## Indications for use
This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K202371
Methodology: https://510kreport.com/methodology