# K222548: Endo Motor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Perfect Medical Instruments Co., Ltd.
- Decided: Apr 26, 2023 after 246 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.
No later device cites it as a predicate yet.
0 of 4 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 5.

## Indications for use
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge 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.

Source page: https://510kreport.com/device/K222548
Methodology: https://510kreport.com/methodology