510(k) · Cleared
ClearedQmix 2IN1 Endodontic Irrigating Solution
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 Feb 14, 2011 as substantially equivalent to K053167 (Dentsply Intl., Inc., 2005) after a 104-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.
- Decided
- Feb 14, 2011
- Review
- 104 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003422 (2001). 7 later devices descend from it, 4 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 deviceK103244 Qmix 2IN1 Endodontic Irrigating SolutionDentsply Intl., Inc. · 2011
- Descendant · cites it directly · 2 of its ownK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- 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
- Descendant · 2 generations on · 0 of its ownK160577 PacEndo ChlorhexidinePac-Dent International, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020 · 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
- K160577PacEndo ChlorhexidinePac-Dent International, Inc. · 2016 · 2 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) | K103244 | Qmix 2IN1 Endodontic Irrigating Solution | Dentsply Intl., Inc. | 2011 | — |
| +1 | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +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 | — |
| +2 | K160577 | PacEndo Chlorhexidine | Pac-Dent International, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K053167 | Biopure Mtad Root Canal CleanserSummary page 1…lass: Unclassified * Product Code: KJJ 3. Predicate Device: Bioure MTAD Root Canal Cleanser, DENTSPLY International, K053 167 4. Description of Device: QMixTM 2inl Endodontic Irrigating Solution is a premixed dual-action device that… | 2005 |
What descends from it? (7)
4 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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193409 (Inter-Med/Vista Dental Products, 2020) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K053167.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
QMixTM 2inl Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103244: Qmix 2IN1 Endodontic Irrigating Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103244
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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