# K153528: PacEndo EDTA

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Feb 1, 2016 after 54 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: 2 generations back to K950365 (1995). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072555: Edta Plus, Essential Dental Systems, Inc. (2007) Summary page 4.

## Most influential descendants
- K193409: Vista Rinse, Vista Rinse Plus (2020), 2 descendants of its own
- K193357: V-Mix (2020), 1 descendant of its own
- K211813: Triton (2021), 0 descendants of its own

## Indications for use
PacEndo EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Source page: https://510kreport.com/device/K153528
Methodology: https://510kreport.com/methodology