Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PHR · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
318 daysmedian FDA review time
1394 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | 2025-05-07 | 100 | 0 |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 | 318 | 0 |
| K240059 | FAgamin® | Tedequim Srl | 2024-05-16 | 129 | 0 |
| K240619 | e-SDF | Kids-E-Dental Llp | 2024-03-06 | 1 | 0 |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | 2023-10-27 | 438 | 0 |
| K222323 | Black Diamond | Elevate Oral Care, LLC | 2023-06-23 | 325 | 0 |
| K172047 | Riva Star | Sdi Limited | 2018-04-11 | 279 | 0 |
| K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | 2014-07-31 | 1394 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda