# K143418: STRONG Dental Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jul 31, 2015 after 245 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: 4 generations back to K971350 (1997). 6 ancestors in all.
2 later devices descend 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)
- K100192: Strong Dental Handpieces, Saeshin Precision Co., Ltd. (2010) Summary page 6.

## Most influential descendants
- K171436: STRONG Dental Handpieces (2018), 1 descendant of its own
- K182892: TRAUS Dental Handpieces (2019), 0 descendants of its own

## Indications for use
The STRONG Dental Handpieces, ACL(B)-03C and ACL(B)-03F, 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 tecth and teeth bone for e.g. impacted third molars and complicated extractions

Source page: https://510kreport.com/device/K143418
Methodology: https://510kreport.com/methodology