# K160577: PacEndo Chlorhexidine

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Jul 25, 2016 after 146 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: 6 generations back to K003422 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112250: CHX=CHX Plus, Inter-Med, Inc. (2011) Summary page 4.

## Indications for use
PacEndo Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.

Source page: https://510kreport.com/device/K160577
Methodology: https://510kreport.com/methodology