# K141352: Endocyn Root Canal Irrigation Solution

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Aug 18, 2014 after 87 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: 5 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)
- K061689: Aquatine EC Endodontic Cleanser, Puricore, Inc. (2006) Summary page 4.
- K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra, Inter-Med, Inc. (2009) Summary page 4.

## Indications for use
Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation.

Source page: https://510kreport.com/device/K141352
Methodology: https://510kreport.com/methodology