# K061689: Aquatine EC Endodontic Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Aug 24, 2006 after 70 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: 3 generations back to K003422 (2001). 5 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962743: Pulpdent Sodium Hypochlorite Solution, Pulpdent Corp. (1996) Summary page 1.
- K992919: Oxy-Glide Root Canal Cleanser & Lub., Super Glide, Inc. (1999) Summary page 1.
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 1.
- (no number) Endopure Root Canal Cleanser: named in the summary without a submission number

## Most influential descendants
- K082470: Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-Xtra (2009), 6 descendants of its own
- K070401: Endo-CHX (2007), 2 descendants of its own
- K193357: V-Mix (2020), 1 descendant of its own
- K112250: CHX=CHX Plus (2011), 1 descendant of its own
- K211813: Triton (2021), 0 descendants of its own

## Indications for use
AquatineTM EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

Source page: https://510kreport.com/device/K061689
Methodology: https://510kreport.com/methodology