FDA applicant
Nobelpharma USA, Inc.
FDA records 64 decisions for Nobelpharma USA, Inc. (Chicago, IL) from 1990 to 1999: 64 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 20 predicates, 16 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nobelpharma USA, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Nobelpharma USA, Inc. since 2007.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Nobelpharma USA, Inc.’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 “Nobelpharma”
FDA records each applicant name separately; these may or may not be the same firm.