# K123538: Epien Root Canal Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Epien Medical, Inc.
- Decided: Feb 1, 2013 after 77 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063703: Citric Acid 20% Solution, Model 329, Ultradent Products, Inc. (2006) Summary page 1.
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005)
- K061689: Aquatine EC Endodontic Cleanser, Puricore, Inc. (2006) Summary page 1.

## Indications for use
EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.

Source page: https://510kreport.com/device/K123538
Methodology: https://510kreport.com/methodology