Digital X-Ray DentiMax Pro Imaging System

FDA 510(k) K251206 · Dentimax, Inc.

Substantially Equivalent

510(k) numberK251206

Submission

Device name
Digital X-Ray DentiMax Pro Imaging System
Applicant
Dentimax, Inc.
Mesa, AZ, US
Received
April 18, 2025
Decision date
September 24, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

Other 510(k)s with product code MUH

510(k)DeviceApplicantDecision
K251793SOTA Cloud Smart Sensor (1.5)MUH · Traditional Sota Cloud Corp.03/03/2026SE
K252570EzSensor HD, EzSensor UHDMUH · Special Qpix Solutions, Inc.11/10/2025SE
K250687Cocoon Solo (DX-7020s)MUH · Traditional Dexcowin Global, Inc.10/24/2025SE
K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional VATECH Co., Ltd.10/25/2024SE
K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)MUH · Special Qpix Solutions, Inc.10/11/2024SE
K241649DUO1 and DUO2MUH · Traditional Zinnovi, Inc.07/05/2024SE
K232325RAYSCAN a-ExpertMUH · Traditional Ray Co., Ltd.04/18/2024SE
K231660Digital image scanner of dentalMUH · Traditional Jiangsu Dynamic Medical Technology Co., Ltd.12/20/2023SE
K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional Dental Imaging Technologies Corporation11/21/2023SE
K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)MUH · Abbreviated Tuxedo Imaging, LLC10/20/2023SE

More from Tuxedo Imaging, LLC

510(k)DeviceDecision
K220556OpenSensorX SeriesMUH · Special 04/13/2022SE
K092547Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control BoxMUH · Traditional 10/30/2009SE

Questions and answers

When was Digital X-Ray DentiMax Pro Imaging System cleared by the FDA?

Digital X-Ray DentiMax Pro Imaging System (K251206) received a 510(k) decision of Substantially Equivalent on September 24, 2025, 159 days after the submission was received.

What is the product code of K251206?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.