FDA applicant
Ot Medical GmbH
FDA records 4 decisions for Ot Medical GmbH (Bremen, DE) from 2012 to 2016: 4 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ot Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ot Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Ot 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