FDA applicant

Neodent USA, Inc.

Andover, MA1 decision2014–20140 recalls

FDA records 1 decision for Neodent USA, Inc. (Andover, MA) in 2014: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 5 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 Neodent USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Neodent USA, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Neodent USA, 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?