510(k) K202633

ScanX Edge by Dürr Dental SE — Product Code MUH

K202633 is an FDA 510(k) premarket notification submitted by Dürr Dental SE for the device "ScanX Edge". The FDA issued a decision of Substantially Equivalent on October 7, 2020. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Dürr Dental SE has at least 2 other 510(k) clearances on record.