# K070401: Endo-CHX

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Jul 11, 2007 after 149 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003422 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061689: Aquatine EC Endodontic Cleanser, Puricore, Inc. (2006) Summary page 1.
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 1.

## Most influential descendants
- K112250: CHX=CHX Plus (2011), 1 descendant of its own
- K160577: PacEndo Chlorhexidine (2016), 0 descendants of its own

## Indications for use
ENDO-CHXTM is intended to irrigate and cleanse root canal systems.

Source page: https://510kreport.com/device/K070401
Methodology: https://510kreport.com/methodology