FDA applicant
Nobel Biocare USA, LLC
FDA records 9 decisions for Nobel Biocare USA, LLC (Yorba Linda,, CA) from 2005 to 2014: 9 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Its devices cite 12 predicates, 1 of them its own earlier devices. 34 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nobel Biocare USA, LLC’s devices, and how often a recall has named them.
FDA decisions per year
2in 2014
2026 so far, outlined.
Recalls per year
6in 2021
Class I Class II/III not classified
Planning a device like Nobel Biocare USA, LLC’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.