# K182892: TRAUS Dental Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Nov 26, 2019 after 407 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- 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: 6 generations back to K971350 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171436: STRONG Dental Handpieces, Saeshin Precision Co., Ltd. (2018) Summary page 5.

## Indications for use
The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including: A. Implant placement , including 1. Preparation of the osteotomy site 2. Bone contouring , osteoplasty B. Periodontal surgeries 1. Bone contouring & alveoplasty around living teeth 2. Removal of exostosis C. Bone grafting 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) 2. Harvesting autogen living bone 3. Sinus elevation & grafting of alveolar sockets D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

Source page: https://510kreport.com/device/K182892
Methodology: https://510kreport.com/methodology