FDA applicant

Addent, Inc.

Danbury, CT7 decisions2005–20190 recalls

FDA records 7 decisions for Addent, Inc. (Danbury, CT) from 2005 to 2019: 7 510(k) clearances. Most are in product codes EAZ (Light, Operating, Dental) and NXV (Diagnostic Light, Soft Tissue Detector). Its devices cite 4 predicates, 1 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 Addent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Addent, Inc.

Which product codes does it file in?

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?