# K192649: Endo Motor

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Cicada Dental Instrument Co, Ltd.
- Decided: Mar 12, 2021 after 535 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: 2 generations back to K970339 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor, W&H Dentalwerk Buermoos GmbH (2009) Summary page 5.

## Indications for use
Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.

Source page: https://510kreport.com/device/K192649
Methodology: https://510kreport.com/methodology