# K192809: Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Nx Co., Ltd.
- Decided: Aug 25, 2020 after 329 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: 3 generations back to K971350 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163239: SMARTmatic, Kaltenbach & Voigt GmbH (2017) Summary page 4.
- K093894: Anthogyr Impulsion Implantology Contra-Angle, Anthogyr (2010) Summary page 4.

## Most influential descendants
- K220577: Dental Handpiece, Model CA160, CA160L, and CA500L (2022), 1 descendant of its own
- K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit (2023), 0 descendants of its own

## Indications for use
Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K192809
Methodology: https://510kreport.com/methodology