510(k) · Cleared

Cleared

Endopure Root Canal Cleanser

K032361510(k) TraditionalCleared Jan 12, 2004165-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dentsply Intl. · KJJ Cleanser, Root Canal

Cleared on Jan 12, 2004 as substantially equivalent to K003422 (Super Glide, Inc., 2001) after a 165-day review. Its family tree reaches back 1 generation to 2001. 64 later devices descend from it.

Decided: Jan 12, 2004
Review: 165 days
Class: Class U
Product code: KJJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003422 (2001). 64 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
This deviceK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
Descendant · cites it directly · 63 of its ownK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
Descendant · cites it directly · 28 of its ownK071363 Waterlase and Waterlase MDBiolase Technology, Inc. · 2008
Descendant · 2 generations on · 26 of its ownK090181 Waterlase MDBiolase Technology, Inc. · 2009
Descendant · 2 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
Descendant · 3 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2005high 8 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 64 · See all

K053167Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005 · cites it directly63descendants
K071363Waterlase and Waterlase MDBiolase Technology, Inc. · 2008 · cites it directly28descendants
K090181Waterlase MDBiolase Technology, Inc. · 2009 · 2 generations on26descendants
K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 2 generations on25descendants
K161669Waterlase ExpressBiolase, Inc. · 2016 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003422	Edta Root Canal Cleanser	Super Glide, Inc.	2001	—
0 (this device)	K032361	Endopure Root Canal Cleanser	Dentsply Intl.	2004	—
+1	K053167	Biopure Mtad Root Canal Cleanser	Dentsply Intl., Inc.	2005	—
+1	K071363	Waterlase and Waterlase MD	Biolase Technology, Inc.	2008	—
+2	K090181	Waterlase MD	Biolase Technology, Inc.	2009	—
+2	K101658	Waterlase MD Turbo Plus Model 7200XXX	Biolase Technology, Inc.	2010	1
+3	K161669	Waterlase Express	Biolase, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2008	1	0
2009	4	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2014	3	0
2015	4	0
2016	3	0
2018	3	0
2019	2	0
2020	5	0
2021	4	0
2022	5	0
2023	2	0
2024	5	0
2025	4	0
2026	8	0

FIG. 1 — Lineage of K032361, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K003422	Edta Root Canal Cleanser Summary page 1 …Cleanser CLASSIFICATION NAME: Root Canal Cleanser (unclassified) PREDICATE DEVICES: EDTA Root Canal Cleanser K003422 DEVICE DESCRIPTION: EndoPure TM Root Canal Cleanser is a two-part liquid/powder formulation. The mixed solution cleanses the…	Super Glide, Inc.	2001	—

What descends from it? (64)

See all 64

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053167	Biopure Mtad Root Canal Cleanser	Dentsply Intl., Inc.	2005	63
K071363	Waterlase and Waterlase MD	Biolase Technology, Inc.	2008	28

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?

Its one ancestor has no recall.
Of its descendants, K053167 (Dentsply Intl., Inc., 2005) has gone furthest, with 63 descendants of its own.

How does its category compare?

All KJJ devices

KJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KJJ

1in 2025

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KJJ

275in 2020

2007high 275 (2020) · low 94 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KJJ

7in 2019

2007high 7 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KJJ

2in 2025

2007high 3 (2007) · low 0 (2008)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?

Used to chemically clean and disinfect a root canal system after endodontic instrumentation

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032361: Endopure Root Canal Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032361

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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