Cleared Traditional

Digital X-Ray DentiMax Pro Imaging System

K251206 · Dentimax, Inc. · Radiology

Sep 2025

Decision

159d

Days

Class 2

Risk

About This 510(k) Submission

K251206 is an FDA 510(k) clearance for the Digital X-Ray DentiMax Pro Imaging System, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Dentimax, Inc. (Mesa, US). The FDA issued a Cleared decision on September 24, 2025, 159 days after receiving the submission on April 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K251206 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	September 24, 2025
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF