Bego U.S.A.: FDA clearances and approvals
Bego U.S.A. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 5 | 5 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
Review panels
- Dental (7)
Most recent Bego U.S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033279 | GOLD DENTAL CASTING ALLOYS | EJT | 2004-01-15 | 97 |
| K032136 | WIROBOND C | EJH | 2003-09-04 | 55 |
| K983082 | BEGOCER G | EJT | 1998-10-28 | 56 |
| K983080 | AUROLLOYD KF | EJT | 1998-10-28 | 56 |
| K983079 | PLATINLLOYD 100 | EJT | 1998-10-23 | 51 |
| K983078 | BEGOPAL | EJS | 1998-10-23 | 51 |
| K983077 | BIO PONTOSTAR | EJT | 1998-10-23 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Bego U.S.A..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bego U.S.A. have?
Bego U.S.A. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 3 product codes in 1 review panel.
How long does FDA take to clear Bego U.S.A.'s 510(k)s?
The median time from FDA receipt to decision across Bego U.S.A.'s cleared 510(k)s is 55 days.
What devices does Bego U.S.A. make?
Its most frequent FDA product codes are EJT (Alloy, Gold-Based Noble Metal, 5); EJH (Alloy, Metal, Base, 1); EJS (Alloy, Other Noble Metal, 1).
Has Bego U.S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bego U.S.A. Related entities may recall under other names.
Next steps
- See all 7 Bego U.S.A. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Bego U.S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.