# K181129: STRONG Dental Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jan 31, 2019 after 276 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K212043: Traus Endo (2022), 0 descendants of its own

## Indications for use
The Strong Dental Handpiece, ACL(B)–46EP is intended for 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/K181129
Methodology: https://510kreport.com/methodology