510(k) · Cleared
ClearedIrritrol, EDS Combo-Rinse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essential Dental Systesm, Inc. · KJJ Cleanser, Root Canal
Cleared on Feb 25, 2015 as substantially equivalent to K103244 (Dentsply Intl., Inc., 2011) after a 50-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Feb 25, 2015
- Review
- 50 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003422 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 3 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 2 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 1 generation backK103244 Qmix 2IN1 Endodontic Irrigating SolutionDentsply Intl., Inc. · 2011
- This deviceK150020 Irritrol, EDS Combo-RinseEssential Dental Systesm, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −3 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −2 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −1 | K103244 | Qmix 2IN1 Endodontic Irrigating Solution | Dentsply Intl., Inc. | 2011 | — |
| 0 (this device) | K150020 | Irritrol, EDS Combo-Rinse | Essential Dental Systesm, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K103244 | Qmix 2IN1 Endodontic Irrigating SolutionSummary page 4…Device class: Unclassified Product Code: KJJ 3. Predicate Device Information: 1. QMixTM 2in1 Endodontic Irrigating Solution, Dentsply International, K103244 4. Device Description: IrritrolTM is an aqueous solution for use during the irrigation phase of endodontic root… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K103244.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
Irritrol™ is intended to cleanse and disinfect root canal systems after endodontic instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150020 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150020: Irritrol, EDS Combo-Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150020
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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