# K130180: Cleanser Root Canal

- Pathway: 510(k) (Traditional)
- Applicant: Cerkamed Wojciech Pawlowski
- Decided: Oct 3, 2013 after 251 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)
- 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 1.
- K962743: Pulpdent Sodium Hypochlorite Solution, Pulpdent Corp. (1996) Summary page 1.

## Indications for use
Liquid used for root canal rinsing during endodontic treatment. During mechanical canal widening it removes the non-vital pulp debris. It cleans the canal and removes at the same time smear layer in order to expose dentinal tubuli orifices before canal filling.

Source page: https://510kreport.com/device/K130180
Methodology: https://510kreport.com/methodology