# K123582: Endo a Class

- Pathway: 510(k) (Traditional)
- Applicant: Saeyang Microtech Co., Ltd.
- Decided: Aug 16, 2013 after 269 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: 2 generations back to K970339 (1997). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092833: Endomax Cordless Endodontic Handpiece, Dentamerica (2010) Summary page 1.
- K970339: Tri Auto ZX, J. Morita USA, Inc. (1997) Summary page 1.
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor, W&H Dentalwerk Buermoos GmbH (2009) Summary page 2.

## Most influential descendants
- K143411: Traus Endo (2015), 1 descendant of its own
- K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit (2023), 0 descendants of its own
- K212043: Traus Endo (2022), 0 descendants of its own

## Indications for use
This application area extends to endlodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

Source page: https://510kreport.com/device/K123582
Methodology: https://510kreport.com/methodology