# K220829: Endo Motor

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Coxo Medical Instrument Co., Ltd.
- Decided: May 18, 2023 after 422 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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 K970339 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201993: E-connect S Endo Motor with built-in Apex Locator, Changzhou Sifary Medical Technology Co., Ltd. (2021) Summary page 7.

## Most influential descendants
- K252223: Alpha Endo Handpiece (Alpha Endo) (2025), 0 descendants of its own
- K243692: EnDrive (EnDriveUS) (2025), 0 descendants of its own

## Indications for use
C-SMART-1 PRO, C-SMART-1 PILOT, C-SMART-MINI AP: The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-Smart-mini: The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Source page: https://510kreport.com/device/K220829
Methodology: https://510kreport.com/methodology