FDA applicant

Ivoclar USA, Inc.

Chicago, IL11 decisions1984–20010 recalls

FDA records 11 decisions for Ivoclar USA, Inc. (Chicago, IL) from 1984 to 2001: 11 510(k) clearances. Most are in product codes ELM (Denture, Plastic, Teeth) and EBI (Resin, Denture, Relining, Repairing, Rebasing). No recall is 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 Ivoclar USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivoclar USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ivoclar 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 “Ivoclar”

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

Ivoclar North America, Inc. 131 Ivoclar Vivadent, Inc. 97 Ivoclar Vivadent, Agin 1

Ivoclar USA, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ivoclar”