510(k) K021542

ADC DENTAL by Agfa Corp. — Product Code MUH

K021542 is an FDA 510(k) premarket notification submitted by Agfa Corp. for the device "ADC DENTAL". The FDA issued a decision of Substantially Equivalent on August 6, 2002. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Agfa Corp. has at least 10 other 510(k) clearances on record.