510(k) Report

FDA applicant

Global Dental Products, Inc.

Wantagh, NY2 decisions2003–20060 recalls

FDA records 2 decisions for Global Dental Products, Inc. (Wantagh, NY) from 2003 to 2006: 2 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EMA (Cement, Dental). Its devices cite 2 predicates, 0 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 Global Dental Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Global Dental Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Global Dental Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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