# K201292: Traus SIP20

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Feb 11, 2021 after 273 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 3 generations back to K002469 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123695: Traus SIP10, Saeshin Precision Co., Ltd. (2012) Summary page 4.

## Indications for use
TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanical rotating root canal preparation.

Source page: https://510kreport.com/device/K201292
Methodology: https://510kreport.com/methodology