# K052515: Siroendo

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Mar 31, 2006 after 198 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: 3 generations back to K970339 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031204: Dentaport ZX, J. Morita USA, Inc. (2003) Summary page 1.

## Indications for use
The SiroEndo is intended for dental root canal length measurement and root canal treatment.

Source page: https://510kreport.com/device/K052515
Methodology: https://510kreport.com/methodology