# K143411: Traus Endo

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jun 29, 2015 after 213 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: 4 generations back to K971350 (1997). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123582: Endo a Class, Saeyang Microtech Co., Ltd. (2013) Summary page 5.
- K111616: E-CUBE, Saeshin Precision Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K212043: Traus Endo (2022), 0 descendants of its own

## Indications for use
The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

Source page: https://510kreport.com/device/K143411
Methodology: https://510kreport.com/methodology