# K092412: Strong Implant Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Sep 3, 2009 after 28 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, 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: 2 generations back to K971350 (1997). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040674: Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles, Anthogyr (2004) Summary page 1.

## Most influential descendants
- K111616: E-CUBE (2011), 10 descendants of its own
- K133298: Endo Smart (2014), 6 descendants of its own
- K153285: EMS-200 (2016), 5 descendants of its own
- K202906: EndoPilot2 (2021), 4 descendants of its own
- K100192: Strong Dental Handpieces (2010), 3 descendants of its own

## Indications for use
The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including: * Endodontic surgeries, such as root canal preparations * Implant surgery such as perforating the bone, tapping and threading procedures * General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth

Source page: https://510kreport.com/device/K092412
Methodology: https://510kreport.com/methodology