# K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Nx Co., Ltd.
- Decided: Nov 9, 2023 after 58 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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 K971350 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220577: Dental Handpiece, Model CA160, CA160L, and CA500L, Micro-Nx Co., Ltd. (2022) Summary page 5.
- K123582: Endo a Class, Saeyang Microtech Co., Ltd. (2013) Summary page 5.

## Indications for use
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K232810
Methodology: https://510kreport.com/methodology