Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bego U.S.A. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
97 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033279 | GOLD DENTAL CASTING ALLOYS | Bego U.S.A. | 2004-01-15 | 97 | 0 |
| K032136 | WIROBOND C | Bego U.S.A. | 2003-09-04 | 55 | 0 |
| K983082 | BEGOCER G | Bego U.S.A. | 1998-10-28 | 56 | 0 |
| K983080 | AUROLLOYD KF | Bego U.S.A. | 1998-10-28 | 56 | 0 |
| K983078 | BEGOPAL | Bego U.S.A. | 1998-10-23 | 51 | 0 |
| K983077 | BIO PONTOSTAR | Bego U.S.A. | 1998-10-23 | 51 | 0 |
| K983079 | PLATINLLOYD 100 | Bego U.S.A. | 1998-10-23 | 51 | 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