510(k) · Cleared
ClearedConsepsis (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultradent Products, Inc. · LBH Varnish, Cavity
Cleared on Jul 8, 1993 after a 280-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jul 8, 1993
- Review
- 280 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK924982 Consepsis (TM)Ultradent Products, Inc. · 1993
- 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 · cites it directly · 1 of its ownK112250 CHX=CHX PlusInter-Med, Inc. · 2011
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K112250CHX=CHX PlusInter-Med, Inc. · 2011 · cites it directly1descendant
- K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021 · 3 generations on0descendants
- K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924982 | Consepsis (TM) | Ultradent Products, Inc. | 1993 | — |
| +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 | — |
| +1 | K112250 | CHX=CHX Plus | Inter-Med, Inc. | 2011 | — |
| +3 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021 | — |
| +3 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 12.8 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 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?
- 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/K924982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924982: Consepsis (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924982
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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