FDA applicant
Medentika GmbH
FDA records 10 decisions for Medentika GmbH (Huegelsheim, DE) from 2015 to 2025: 10 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 216 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 9 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 Medentika GmbH’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Medentika 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