# K191276: Dental Electrical Motor iRoot Pro

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
- Decided: Jun 30, 2020 after 414 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)
- K170275: Tri Auto ZX2, J. Morita USA, Inc. (2017) Summary page 6.

## Indications for use
The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

Source page: https://510kreport.com/device/K191276
Methodology: https://510kreport.com/methodology