FDA applicant

South American Dental Exporting Corp.

Hialeah, FL1 decision1994–19940 recalls

FDA records 1 decision for South American Dental Exporting Corp. (Hialeah, FL) in 1994: 1 510(k) clearance. All are in product code ELZ (Crown, Preformed). 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 South American Dental Exporting Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for South American Dental Exporting Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — South American Dental Exporting Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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South American Dental Exporting Corp.

Which product codes does it file in?

What has FDA decided for it lately?