FDA applicant
Medical Instinct Deutschland GmbH
FDA records 2 decisions for Medical Instinct Deutschland GmbH (Bovenden, DE) from 2019 to 2021: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 2 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 Medical Instinct Deutschland GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Medical Instinct Deutschland 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