510(k) Report

FDA applicant

Nobel Biocare Uas, Inc.

Yorba Linda,, CA31 decisions1997–200545 recalls

FDA records 31 decisions for Nobel Biocare Uas, Inc. (Yorba Linda,, CA) from 1997 to 2005: 31 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 71 predicates, 15 of them its own earlier devices. 45 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 Nobel Biocare Uas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nobel Biocare Uas, Inc. since 2007.

Recalls per year

16in 2019

2015: 272016: 22019: 16
2007high 27 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nobel Biocare Uas, 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 “Nobel”

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