FDA applicant
Biodenta Swiss AG
FDA records 11 decisions for Biodenta Swiss AG (Berneck, St.Gallen, CH) from 2010 to 2015: 11 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Its devices cite 32 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 Biodenta Swiss AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Biodenta Swiss AG’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