Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Silmet , Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | Silmet , Ltd. | 2011-09-08 | 209 | 0 |
| K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | Silmet , Ltd. | 2011-02-02 | 97 | 0 |
| K101869 | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) | Silmet , Ltd. | 2010-09-29 | 89 | 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