510(k) K251206

Digital X-Ray DentiMax Pro Imaging System by Dentimax, Inc. — Product Code MUH

K251206 is an FDA 510(k) premarket notification submitted by Dentimax, Inc. for the device "Digital X-Ray DentiMax Pro Imaging System". The FDA issued a decision of Substantially Equivalent on September 24, 2025. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Dentimax, Inc. has at least 2 other 510(k) clearances on record.