510(k) Report

FDA applicant

Nobelpharma USA, Inc.

Chicago, IL64 decisions1990–19992 recalls

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, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

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

2019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nobelpharma USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Nobelpharma”

FDA records each applicant name separately; these may or may not be the same firm.