510(k) · Cleared
ClearedTriton
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med / Vista Dental · KJJ Cleanser, Root Canal
Cleared on Aug 18, 2021 as substantially equivalent to K193357 (Inter-Med/Vista Dental Products, 2020) after a 68-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Aug 18, 2021
- Review
- 68 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003422 (2001). 14 ancestors in all, the oldest K950365 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 5 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 4 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 3 generations backK061689 Aquatine EC Endodontic CleanserPuricore, Inc. · 2006
- 2 generations backK082470 Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to…Inter-Med, Inc. · 2009 · Recalled
- 1 generation backK193357 V-MixInter-Med/Vista Dental Products · 2020
- This deviceK211813 TritonInter-Med / Vista Dental · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −5 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −4 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −3 | K061689 | Aquatine EC Endodontic Cleanser | Puricore, Inc. | 2006 | — |
| −2 | K082470 | Sodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower… | Inter-Med, Inc. | 2009 | 7 |
| −1 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| 0 (this device) | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K193357 | V-MixSummary page 4…y: Brett Arand Device Name Proprietary Name: Triton Common Name: Cleanser, Root Canal Product Code: KJJ Device Class: Unclassified Predicate Device V-Mix (K193357) by Inter-Med / Vista Dental Products o Common Name: Cleanser, Root Canal o Product Code: KJJ o Device Class: Uncl… | 2020 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All KJJ devicesKJJ Cleanser, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
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/K211813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211813: Triton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K211813
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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