# K252223: Alpha Endo Handpiece (Alpha Endo)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Superline Technology CO., LTD.
- Decided: Oct 16, 2025 after 92 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 5.

## Indications for use
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.

Source page: https://510kreport.com/device/K252223
Methodology: https://510kreport.com/methodology