FDA applicant
Nobel Biocare AB
FDA records 96 decisions for Nobel Biocare AB (Yorba Linda,, CA) from 2002 to 2026: 96 510(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 175 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 173 predicates, 101 of them its own earlier devices. 36 recalls are linked to its devices.
FDA’s records also spell it “Nobel Biocare AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nobel Biocare AB’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
7in 2019
Class I Class II/III not classified
Planning a device like Nobel Biocare AB’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 “Nobel”
FDA records each applicant name separately; these may or may not be the same firm.