FDA applicant
Institut Straumann AG
FDA records 92 decisions for Institut Straumann AG (Basel, CH) from 1990 to 2026: 92 510(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 155 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 157 predicates, 60 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Institut Straumann SA”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Institut Straumann AG’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Institut Straumann 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) ReportOther applicant names beginning “Institut”
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