510(k) · Cleared
Recalled · Class II · 2023Oral-B 5% Sodium Fluoride Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Young Dental Manufacturing Co. 1, LLC · LBH Varnish, Cavity
Cleared on May 20, 2016 as substantially equivalent to K040098 (Medical Products Laboratories, Inc., 2004) after a 183-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 20, 2016
- Review
- 183 days
- Class
- Class II
- Product code
- LBH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040098 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK040098 VarnishamericaMedical Products Laboratories, Inc. · 2004
- This deviceK153334 Oral-B 5% Sodium Fluoride VarnishYoung Dental Manufacturing Co. 1, LLC · 2016
- Descendant · cites it directly · 0 of its ownK192381 DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing…Scientific Pharmaceuticals · 2020
Most influential descendants
Showing 1 of 1 · See all- K192381DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…Scientific Pharmaceuticals · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040098 | Varnishamerica | Medical Products Laboratories, Inc. | 2004 | — |
| 0 (this device) | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016 | — |
| +1 | K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing… | Scientific Pharmaceuticals | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K040098 | VarnishamericaSummary page 4…n Panel: Dental Predicate Device(s): VarnishAmerica 5% Sodium Fluoride Varnish, Medical Products Laboratories, Inc. K040098, cleared February 4, 2004 Purpose and Description Oral-B 5% Sodium Fluoride Varnish is a… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2023 | Class II | Z-1697-2023 | Employee error | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. |
| Oct 30, 2019 | Class II | Z-0661-2020 | Process control | Product shelf life may be shorter than that indicated on the label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and
for the reduction of post-operative sensitivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153334: Oral-B 5% Sodium Fluoride Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153334
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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