FDA applicant

Dentimax, Inc.

Mesa, AZ3 decisions2009–20250 recalls

FDA records 3 decisions for Dentimax, Inc. (Mesa, AZ) from 2009 to 2025: 3 510(k) clearances. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dentimax”.

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 Dentimax, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Dentimax, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Dentimax, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?