FDA applicant

GC America, Inc.

Alsip, IL129 decisions1993–20260 recalls

FDA records 129 decisions for GC America, Inc. (Alsip, IL) from 1993 to 2026: 129 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 204 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 99 predicates, 49 of them its own earlier devices. 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 GC America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007high 11 (2008) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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GC America, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?