# K150020: Irritrol, EDS Combo-Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systesm, Inc.
- Decided: Feb 25, 2015 after 50 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103244: Qmix 2IN1 Endodontic Irrigating Solution, Dentsply Intl., Inc. (2011) Summary page 4.

## Indications for use
Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.

Source page: https://510kreport.com/device/K150020
Methodology: https://510kreport.com/methodology