Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OIV — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223182 | Arial Dental, Mistral Dental Amalgam, World Work Dental Amal | Worldwork S.R.L | 2023-05-01 | 202 | 0 |
| K140125 | NEW STETIC DENTAL AMALGAM ALLOY | New Stetic | 2014-04-29 | 103 | 0 |
| K081273 | ULTRACAPS S | Sdi , Ltd. | 2008-07-10 | 66 | 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