Cleared Special

OpenSensorX Series

K220556 · Dentimax, Inc. · Radiology

Apr 2022

Decision

44d

Days

Class 2

Risk

About This 510(k) Submission

K220556 is an FDA 510(k) clearance for the OpenSensorX Series, 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 April 13, 2022, 44 days after receiving the submission on February 28, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K220556 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2022
Decision Date	April 13, 2022
Days to Decision	44 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF