FDA applicant

Gac Intl., Inc.

Central Islip, NY13 decisions1977–19990 recalls

FDA records 13 decisions for Gac Intl., Inc. (Central Islip, NY) from 1977 to 1999: 13 510(k) clearances. Most are in product codes EJF (Bracket, Metal, Orthodontic) and DZC (Wire, Orthodontic). 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 Gac Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gac Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gac Intl., 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?