510(k) · Cleared
ClearedVista Rinse, Vista Rinse Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med/Vista Dental Products · KJJ Cleanser, Root Canal
Cleared on Sep 9, 2020 as substantially equivalent to K103244 (Dentsply Intl., Inc., 2011) and 1 other predicate after a 275-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 9, 2020
- Review
- 275 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003422 (2001). 8 ancestors in all, the oldest K950365 (1995). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- Descendant · cites it directly · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 2 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Most influential descendants
Showing 2 of 2 · See allView 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) | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +1 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +2 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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? (2)
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…us Common Name: Cleanser, Root Canal Product Code: KJJ Device Class: Unclassified 3. Predicate Devices Q-Mix 2in1 Endodontic Irrigation Solution (K103244) by Dentsply Sirona o Common Name: Cleanser, Root Canal o Product Code: KJJ o Device Class: Unclassified… | 2011 |
| * | K153528 | PacEndo EDTASummary page 4…on Solution (K103244) by Dentsply Sirona o Common Name: Cleanser, Root Canal o Product Code: KJJ o Device Class: Unclassified PacEndo EDTA (K153528) by Pac-Dent International, Inc. o Common Name: Cleanser, Root Canal o Product Code: KJJ o Device Class:… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193357 | V-Mix | 2020 | 1 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K193357 (Inter-Med/Vista Dental Products, 2020) has gone furthest, with 1 descendant of its own.
- 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. 2020, 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?
Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193409: Vista Rinse, Vista Rinse Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193409
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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