510(k) · Cleared
ClearedBiopure Mtad Root Canal Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · KJJ Cleanser, Root Canal
Cleared on Dec 8, 2005 as substantially equivalent to K032361 (Dentsply Intl., 2004) after a 24-day review. Its family tree reaches back 2 generations to 2001. 63 later devices descend from it.
- Decided
- Dec 8, 2005
- Review
- 24 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003422 (2001). 63 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 1 generation backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- This deviceK053167 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
- Descendant · 3 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- 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
- K190319Waterlase Laser System FamilyBiolase, Inc. · 2019 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −1 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| 0 (this device) | 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 | — |
| +3 | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K032361 | Endopure Root Canal CleanserSummary page 1…ANAL CLEANSER CLASSIFICATION NAME: Root canal cleanser, Unclassified PREDICATE DEVICES: EndoPureTM Root Canal Cleanser, K032361 DEVICE DESCRIPTION: BIOPURETM MTADTM ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and P… | 2004 |
What descends from it? (63)
See all 639 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071363 | Waterlase and Waterlase MD | 2008 | 28 |
| K092232 | Modification to:Vashe Wound Cleansing System, Model 9000-0014 | 2009 | 16 |
| K061689 | Aquatine EC Endodontic Cleanser | 2006 | 11 |
| K103244 | Qmix 2IN1 Endodontic Irrigating Solution | 2011 | 7 |
| K070401 | Endo-CHX | 2007 | 2 |
| K193357 | V-Mix | 2020 | 1 |
| K112250 | CHX=CHX Plus | 2011 | 1 |
| K123538 | Epien Root Canal Cleanser | 2013 | 0 |
| K060901 | Vashe Wound Cleansing System | 2006 | 0 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071363 (Biolase Technology, Inc., 2008) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K032361.
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?
BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and
disinfect the root canal system after endodontic instrumentation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K053167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053167: Biopure Mtad Root Canal Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053167
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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