Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Bego Implant Systems GmbH & Co. KG · 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) |
|---|---|---|---|---|---|
| K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, B | Bego Implant Systems GmbH & Co. KG | 2021-02-18 | 266 | 0 |
| K201700 | BEGO Semados® RS/RSX Implant System | Bego Implant Systems GmbH & Co. KG | 2021-01-13 | 205 | 0 |
| K090716 | BEGO SEMADOS S-LINE | Bego Implant Systems GmbH & Co. KG | 2009-10-06 | 202 | 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