# K243692: EnDrive (EnDriveUS)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Research (A.T.R.) S.R.L.
- Decided: Aug 22, 2025 after 266 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: 4 generations back to K970339 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220829: Endo Motor, Foshan Coxo Medical Instrument Co., Ltd. (2023) Summary page 6.

## Indications for use
EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator.

Source page: https://510kreport.com/device/K243692
Methodology: https://510kreport.com/methodology