# K213947: Ultrasonic Endo Activation Device (Model:Actor I pro)

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
- Decided: Sep 8, 2022 after 265 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: 7 generations back to K971350 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202906: EndoPilot2, Schlumbohm GmbH & Co. KG (2021) Summary page 4.

## Indications for use
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for root- canal cleaning and preparation. The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

Source page: https://510kreport.com/device/K213947
Methodology: https://510kreport.com/methodology