Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Forestadent Bernhard Forster GmbH · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110275 | ORTHO EASY PIN | Forestadent Bernhard Forster GmbH | 2011-06-03 | 123 | 0 |
| K090933 | BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS | Forestadent Bernhard Forster GmbH | 2009-06-05 | 64 | 0 |
| K925240 | FACEBOW | Forestadent Bernhard Forster GmbH | 1993-06-18 | 245 | 0 |
| K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH | 1993-05-27 | 239 | 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