# K212043: Traus Endo

- Pathway: 510(k) (Special)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jun 24, 2022 after 359 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). 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)
- K143411: Traus Endo, Saeshin Precision Co., Ltd. (2015) Summary page 5.
- K181129: STRONG Dental Handpieces, Saeshin Precision Co., Ltd. (2019) Summary page 5.

## Indications for use
The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, 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/K212043
Methodology: https://510kreport.com/methodology