FDA applicant

Candulor USA, Inc.

Amherst, NY2 decisions2010–20120 recalls

FDA records 2 decisions for Candulor USA, Inc. (Amherst, NY) from 2010 to 2012: 2 510(k) clearances. Most are in product codes ELM (Denture, Plastic, Teeth) and EBG (Crown And Bridge, Temporary, Resin). 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 Candulor USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Candulor USA, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Candulor USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?