510(k) · Cleared
ClearedSmearclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · KJJ Cleanser, Root Canal
Cleared on Mar 5, 2003 after a 75-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 5, 2003
- Review
- 75 days
- Class
- Class U
- Product code
- KJJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK024198 SmearclearSybron Dental Specialties, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK072555 Edta PlusEssential Dental Systems, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK153528 PacEndo EDTAPac-Dent International, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK193409 Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020
- Descendant · 4 generations on · 1 of its ownK193357 V-MixInter-Med/Vista Dental Products · 2020
- Descendant · 5 generations on · 0 of its ownK211813 TritonInter-Med / Vista Dental · 2021
Most influential descendants
Showing 5 of 5 · See all- K072555Edta PlusEssential Dental Systems, Inc. · 2007 · cites it directly4descendants
- K153528PacEndo EDTAPac-Dent International, Inc. · 2016 · 2 generations on3descendants
- K193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products · 2020 · 3 generations on2descendants
- K193357V-MixInter-Med/Vista Dental Products · 2020 · 4 generations on1descendant
- K211813TritonInter-Med / Vista Dental · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024198 | Smearclear | Sybron Dental Specialties, Inc. | 2003 | — |
| +1 | K072555 | Edta Plus | Essential Dental Systems, Inc. | 2007 | — |
| +2 | K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016 | — |
| +3 | K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020 | — |
| +4 | K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020 | — |
| +5 | K211813 | Triton | Inter-Med / Vista Dental | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | — | PulpDent's EDTA Solution Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072555 | Edta Plus | 2007 | 4 |
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, K072555 (Essential Dental Systems, Inc., 2007) has gone furthest, with 4 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 | — |
What is it indicated for?
The intended use of SmearClear is designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024198 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024198: Smearclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024198
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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