510(k) · Cleared
ClearedFAgamin®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tedequim Srl · PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Cleared on May 16, 2024 as substantially equivalent to K102973 (Cooley Consulting, Inc., 2014) after a 129-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- May 16, 2024
- Review
- 129 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 deviceK240059 FAgamin®Tedequim Srl · 2024
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) | K240059 | FAgamin® | Tedequim Srl | 2024 | — |
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 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? (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 5….3260 Product Code PHR III) Predicate Device 510(k) Number K102973 Applicant Elevate Oral Care (named as ADP… | 2014 |
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. 2024, 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 dentinal hypersensitivity. For use in adults over the age of 21.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240059: FAgamin®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240059
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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