# K171436: STRONG Dental Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jan 5, 2018 after 234 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: 5 generations back to K971350 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143418: STRONG Dental Handpieces, Saeshin Precision Co., Ltd. (2015) Summary page 5.
- K092412: Strong Implant Handpieces, Saeshin Precision Co., Ltd. (2009) Summary page 11.

## Most influential descendants
- K182892: TRAUS Dental Handpieces (2019), 0 descendants of its own

## Indications for use
The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-62I, ACL(B)-631, ACL(B)-65I and ACL(B)-04C 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/K171436
Methodology: https://510kreport.com/methodology