# K173943: Dental High-speed Handpiece and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Microp Technology (Taiwan), Inc.
- Decided: Jul 24, 2018 after 210 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: 4 generations back to K992011 (1999). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130560: Mastertorque Lux 8900 L, Kaltenbach & Voigt GmbH (2013) Summary page 4.

## Indications for use
The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K173943
Methodology: https://510kreport.com/methodology