510(k) K092547

DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX by Dentimax — Product Code MUH

K092547 is an FDA 510(k) premarket notification submitted by Dentimax for the device "DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX". The FDA issued a decision of Substantially Equivalent on October 30, 2009. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Dentimax has at least 2 other 510(k) clearances on record.