# K151852: PacEndo Sodium Hyprochlorite

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Nov 10, 2015 after 126 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 4.

## Indications for use
PacEndo Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.

Source page: https://510kreport.com/device/K151852
Methodology: https://510kreport.com/methodology