# K192561: Traus SUS20

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jul 13, 2020 after 300 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K042434 (2004). 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)
- K151171: Traus SUS10, Saeshin Precision Co., Ltd. (2015) Summary page 4.

## Indications for use
TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

Source page: https://510kreport.com/device/K192561
Methodology: https://510kreport.com/methodology