510(k) · Cleared
ClearedEdta Root Canal Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Super Glide, Inc. · KJJ Cleanser, Root Canal
Cleared on Jan 19, 2001 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 65 later devices descend from it.
- Decided
- Jan 19, 2001
- Review
- 77 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 0
65 later devices descend from it, 1 citing it directly.
- This deviceK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- Descendant · cites it directly · 64 of its ownK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- Descendant · 2 generations on · 63 of its ownK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- Descendant · 2 generations on · 28 of its ownK071363 Waterlase and Waterlase MDBiolase Technology, Inc. · 2008
- Descendant · 3 generations on · 26 of its ownK090181 Waterlase MDBiolase Technology, Inc. · 2009
- Descendant · 3 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K032361Endopure Root Canal CleanserDentsply Intl. · 2004 · cites it directly64descendants
- K053167Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005 · 2 generations on63descendants
- K071363Waterlase and Waterlase MDBiolase Technology, Inc. · 2008 · 2 generations on28descendants
- K090181Waterlase MDBiolase Technology, Inc. · 2009 · 3 generations on26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| +1 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| +2 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| +2 | K071363 | Waterlase and Waterlase MD | Biolase Technology, Inc. | 2008 | — |
| +3 | K090181 | Waterlase MD | Biolase Technology, Inc. | 2009 | — |
| +3 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (65)
See all 651 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032361 | Endopure Root Canal Cleanser | 2004 | 64 |
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?
- Of its descendants, K032361 (Dentsply Intl., 2004) has gone furthest, with 64 descendants of its own.
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 | — |
https://510kreport.com/device/K003422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003422: Edta Root Canal Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003422
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026