510(k) · Cleared
ClearedSilver Dental Arrest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cooley Consulting, Inc. · PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Cleared on Jul 31, 2014 after a 1,394-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jul 31, 2014
- Review
- 1,394 days
- Class
- Class II
- Product code
- PHR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 6 citing it directly.
- This deviceK102973 Silver Dental ArrestCooley Consulting, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK241041 Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC · 2025
- Descendant · cites it directly · 0 of its ownK240059 FAgamin®Tedequim Srl · 2024
- Descendant · cites it directly · 0 of its ownK240619 e-SDFKids-E-Dental Llp · 2024
- Descendant · cites it directly · 0 of its ownK222459 Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222323 Black DiamondElevate Oral Care, LLC · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241041Silver Fluoride Hypersensitivity VarnishYoung Dental Manufacturing Co. 1, LLC · 2025 · cites it directly0descendants
- K240059FAgamin®Tedequim Srl · 2024 · cites it directly0descendants
- K240619e-SDFKids-E-Dental Llp · 2024 · cites it directly0descendants
- K222459Centrix FluoroSilver Silver Diamine Fluoride 38%Centrix, Inc. · 2023 · cites it directly0descendants
- K222323Black DiamondElevate Oral Care, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102973 | Silver Dental Arrest | Cooley Consulting, Inc. | 2014 | — |
| +1 | K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025 | — |
| +1 | K240059 | FAgamin® | Tedequim Srl | 2024 | — |
| +1 | K240619 | e-SDF | Kids-E-Dental Llp | 2024 | — |
| +1 | K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | 2023 | — |
| +1 | K222323 | Black Diamond | Elevate Oral Care, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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 K241041 Silver Fluoride Hypersensitivity Varnishscore 8.9 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
6 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, K241041 (Young Dental Manufacturing Co. 1, LLC, 2025) has gone furthest, with 0 descendants of its own.
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. 2014, 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?
Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102973: Silver Dental Arrest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102973
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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