FDA applicant
Pro3Dure Medical GmbH
FDA records 6 decisions for Pro3Dure Medical GmbH (Iserlohn, DE) from 2020 to 2026: 6 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Pro3Dure Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pro3Dure Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Pro3Dure Medical 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) Report