# K123695: Traus SIP10

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Dec 18, 2012 after 15 days
- Product code: EKY (Handpiece, Water-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 K002469 (2001). 3 ancestors in all.
4 later devices descend from it; 3 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)
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories, W&H Dentalwerk Buermoos GmbH (2006) Summary page 1.
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11, W&H Dentalwerk Buermoos GmbH (2001)

## Most influential descendants
- K151171: Traus SUS10 (2015), 1 descendant of its own
- K201292: Traus SIP20 (2021), 0 descendants of its own
- K192561: Traus SUS20 (2020), 0 descendants of its own
- K141482: KI-20 (2015), 0 descendants of its own

## Indications for use
The TRAUS SIP 10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

Source page: https://510kreport.com/device/K123695
Methodology: https://510kreport.com/methodology