Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bredent 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) |
|---|---|---|---|---|---|
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024-12-12 | 269 | 0 |
| K152113 | BioHPP - breCAM.BioHPP | Bredent GmbH & Co. KG | 2016-07-21 | 358 | 0 |
| K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | Bredent GmbH & Co. KG | 2010-09-14 | 151 | 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