FDA applicant
Straumann USA
FDA records 66 decisions for Straumann USA (Andover, MA) from 1996 to 2024: 66 510(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 200 for FDA’s reviews in the same codes and years. Its devices cite 178 predicates, 70 of them its own earlier devices. 9 recalls are linked to its devices.
FDA’s records also spell it “Straumann USA, LLC”, “Straumann USA, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Straumann USA’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Straumann USA’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 “Straumann”
FDA records each applicant name separately; these may or may not be the same firm.