510(k) · Cleared
ClearedVivasens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · LBH Varnish, Cavity
Cleared on Oct 17, 2003 after a 207-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Oct 17, 2003
- Review
- 207 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK030922 VivasensIvoclar Vivadent, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK050486 Protect Tooth DesensitizerSunstar Butler · 2005
- Descendant · 2 generations on · 6 of its ownK120109 Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
- Descendant · 3 generations on · 1 of its ownK241489 ReminGelInter-Med, Inc. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K050486Protect Tooth DesensitizerSunstar Butler · 2005 · cites it directly10descendants
- K120109Super Seal Tooth DesensitizerPhoenix Dental, Inc. · 2012 · 2 generations on6descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · 2 generations on2descendants
- K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011 · 2 generations on2descendants
- K241489ReminGelInter-Med, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030922 | Vivasens | Ivoclar Vivadent, Inc. | 2003 | — |
| +1 | K050486 | Protect Tooth Desensitizer | Sunstar Butler | 2005 | — |
| +2 | K120109 | Super Seal Tooth Desensitizer | Phoenix Dental, Inc. | 2012 | — |
| +2 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
| +3 | K241489 | ReminGel | Inter-Med, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 132 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, K050486 (Sunstar Butler, 2005) has gone furthest, with 10 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 | — |
What is it indicated for?
VlvascsnsCO is a film-like varnish for the treatment of hypersensitive teeth. Indications include
- treatment of hypersensitive cervicals
- treatment of tooth sensitivities e.g. due to bleaching procedures
- treatment of sensitivities occumng after professional tooth cleaning, scaling and root-planing procedures
- dentin-protection below restorative materials.
It is Contraindicated if the patient has allergies to any ingredient; If the sensitivity arises from Fulpitis or other dental disease; or for Pulp-capping.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030922 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030922: Vivasens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030922
Report an extraction error
Are you the manufacturer?
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