# K140846: Eds Combo-Rinse

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Jul 25, 2014 after 113 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 1.
- K101485: All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E, Bisco, Inc. (2010) Summary page 1.
- K953504: Microprime, Danville Engineering, Inc. (1995) Summary page 1.

## Indications for use
EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.

Source page: https://510kreport.com/device/K140846
Methodology: https://510kreport.com/methodology