510(k) · Cleared
ClearedAquatine EC Endodontic Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puricore, Inc. · KJJ Cleanser, Root Canal
Cleared on Aug 24, 2006 as substantially equivalent to K962743 (Pulpdent Corp., 1996) and 2 other predicates after a 70-day review. Its family tree reaches back 3 generations to 2001. 11 later devices descend from it.
- Decided
- Aug 24, 2006
- Review
- 70 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003422 (2001). 5 ancestors in all, the oldest K962743 (1996). 11 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 2 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 1 generation backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- This deviceK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK082470 Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to…Inter-Med, Inc. · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK070401 Endo-CHXEssential Dental Systems, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · cites it directly · 1 of its ownK112250 CHX=CHX PlusInter-Med, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K082470Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension…Inter-Med, Inc. · 2009 · cites it directly6descendants
- K070401Endo-CHXEssential Dental Systems, Inc. · 2007 · cites it directly2descendants
- K193357V-MixInter-Med/Vista Dental Products · 2020 · 2 generations on1descendant
- K112250CHX=CHX PlusInter-Med, Inc. · 2011 · cites it directly1descendant
- K211813TritonInter-Med / Vista Dental · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −2 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −1 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| 0 (this device) | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| +1 | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower… | Inter-Med, Inc. | 2009 | 7 |
| +1 | K070401 | Endo-CHX | Essential Dental Systems, Inc. | 2007 | — |
| +2 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +1 | K112250 | CHX=CHX Plus | Inter-Med, Inc. | 2011 | — |
| +3 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KJJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KJJ device
- #1 K241354 Sealer Solventscore 8.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962743 | Pulpdent Sodium Hypochlorite SolutionSummary page 1…ame Endodontic Cleanser Classification Name Cleanser, Root Canal Predicate Devices Pulpdent Sodium Hypochlorite Solution.; Pulpdent Corp., K962743, August 6th, 1996, Oxy-Glide Root Canal Cleanser & Lub.; Super Glide Inc.,… | 1996 |
| * | K992919 | Oxy-Glide Root Canal Cleanser & Lub.Summary page 1…orite Solution.; Pulpdent Corp., K962743, August 6th, 1996, Oxy-Glide Root Canal Cleanser & Lub.; Super Glide Inc., K992919, Nov. 19th, 1999 and Biopure MTAD Root Canal Cleanser Dentsply Intl., Inc., K053167, December 8th, 200… | 1999 |
| * | K053167 | Biopure Mtad Root Canal CleanserSummary page 1…anser & Lub.; Super Glide Inc., K992919, Nov. 19th, 1999 and Biopure MTAD Root Canal Cleanser Dentsply Intl., Inc., K053167, December 8th, 2005. Description Aquatine TM EC Endodontic Cleanser irrigates, cleanses and debrides.… | 2005 |
| * | — | Endopure Root Canal Cleanser Named without a submission number |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K082470 (Inter-Med, Inc., 2009) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K962743.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KJJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KJJ
275in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KJJ
7in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KJJ
2in 2025
MAUDE reports naming product code KJJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 94 | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 7 | 1 |
| 2020 | 3 | 275 | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AquatineTM EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061689: Aquatine EC Endodontic Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061689
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026