FDA applicant
Dreve Dentamid GmbH
FDA records 6 decisions for Dreve Dentamid GmbH (Unna, DE) from 2017 to 2025: 6 510(k) clearances. Most are in product codes ELW (Material, Impression) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Since 2016 its 510(k)s took a median of 259 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Dreve Dentamid GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Dreve Dentamid GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Dreve”
FDA records each applicant name separately; these may or may not be the same firm.