# K222096: Endo Ultrasonic Activator

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Coxo Medical Instrument Co., Ltd.
- Decided: Mar 23, 2023 after 248 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K053555 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053555: Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L, Guilin Woodpecker Medical Instrument Co., Ltd. (2006) Summary page 5.

## Indications for use
For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.

Source page: https://510kreport.com/device/K222096
Methodology: https://510kreport.com/methodology