510(k) · Cleared
ClearedCavity Cleanser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Corp. · LBH Varnish, Cavity
Cleared on Oct 4, 1983 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 4, 1983
- Review
- 69 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK832497 Cavity CleanserDen-Mat Corp. · 1983
- Descendant · cites it directly · 4 of its ownK033938 Clearfil Protect BondKuraray Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK210504 PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK191524 Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019
- Descendant · 2 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K033938Clearfil Protect BondKuraray Medical, Inc. · 2004 · cites it directly4descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
- K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021 · 3 generations on0descendants
- K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019 · 3 generations on0descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K832497 | Cavity Cleanser | Den-Mat Corp. | 1983 | — |
| +1 | K033938 | Clearfil Protect Bond | Kuraray Medical, Inc. | 2004 | — |
| +2 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +3 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021 | — |
| +3 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019 | — |
| +2 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBH? 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 LBH device
- #1 K262243 Profisil Freescore 12.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K033938 | Clearfil Protect Bond | 2004 | 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, K033938 (Kuraray Medical, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 2025
MAUDE reports naming product code LBH, 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 | 8 | 69 | 0 | 4 |
| 2008 | 6 | 79 | 0 | 3 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 7 | 107 | 0 | 7 |
| 2011 | 3 | 72 | 0 | 8 |
| 2012 | 4 | 83 | 0 | 7 |
| 2013 | 6 | 160 | 0 | 27 |
| 2014 | 6 | 204 | 3 | 40 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 2 | 13 |
| 2019 | 2 | — | 1 | 9 |
| 2020 | 5 | 256 | 0 | 10 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 3 | 167 | 0 | 8 |
| 2024 | 3 | 237 | 0 | 6 |
| 2025 | 4 | 223 | 0 | 7 |
| 2026 | 5 | 64 | 0 | — |
https://510kreport.com/device/K832497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K832497: Cavity Cleanser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K832497
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026