510(k) · Cleared
ClearedSilver Fluoride Hypersensitivity Varnish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Young Dental Manufacturing Co. 1, LLC · PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Cleared on Feb 28, 2025 as substantially equivalent to K102973 (Cooley Consulting, Inc., 2014) after a 318-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Feb 28, 2025
- Review
- 318 days
- Class
- Class II
- Product code
- PHR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102973 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK102973 Silver Dental ArrestCooley Consulting, Inc. · 2014
- This deviceK241041 Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102973 | Silver Dental Arrest | Cooley Consulting, Inc. | 2014 | — |
| 0 (this device) | K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025 | — |
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 PHR? 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 PHR device
- #1 K240059 FAgamin®score 7.3 · 1 generation · 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 |
|---|---|---|---|
| * | K102973 | Silver Dental ArrestSummary page 6…tion 21 CFR 872.3260 Type of 510(k) Submission Traditional Legally Marketed Predicate Device Elevate Advantage Arrest (K102973) Description Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosa… | 2014 |
| † | K172047 | Riva Star | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K102973.
How does its category compare?
All PHR devicesPHR Diammine Silver Fluoride Dental Hypersensitivity Varnish: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PHR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHR
Too few PHR 510(k)s in any year since 2007 to give a median.
Recalls per year · PHR
No recall names PHR since 2007.
Adverse event reports per year · PHR
1in 2023
MAUDE reports naming product code PHR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults.
It is intended for professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241041: Silver Fluoride Hypersensitivity Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241041
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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