FDA applicant
Dental Direkt GmbH
FDA records 9 decisions for Dental Direkt GmbH (Spenge, DE) from 2015 to 2024: 9 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 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 Dental Direkt 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 2015.
Planning a device like Dental Direkt 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