FDA applicant

Ivoclar North America, Inc.

Amherst, NY131 decisions1989–20012 recalls

FDA records 131 decisions for Ivoclar North America, Inc. (Amherst, NY) from 1989 to 2001: 131 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EBF (Material, Tooth Shade, Resin). 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 Ivoclar North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivoclar North America, Inc. since 2007.

Recalls per year

2in 2015

2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ivoclar North America, 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 Vivadent, Inc. 97 Ivoclar USA, Inc. 11 Ivoclar Vivadent, Agin 1

Ivoclar North America, 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?

What has been recalled?

Other applicant names beginning “Ivoclar”