# K032361: Endopure Root Canal Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jan 12, 2004 after 165 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: 1 generation back to K003422 (2001). 1 ancestor in all.
64 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003422: Edta Root Canal Cleanser, Super Glide, Inc. (2001) Summary page 1.

## Most influential descendants
- K053167: Biopure Mtad Root Canal Cleanser (2005), 63 descendants of its own
- K071363: Waterlase and Waterlase MD (2008), 28 descendants of its own
- K090181: Waterlase MD (2009), 26 descendants of its own
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own

## Indications for use
Used to chemically clean and disinfect a root canal system after endodontic instrumentation

Source page: https://510kreport.com/device/K032361
Methodology: https://510kreport.com/methodology