510(k) K230095

ScanX Swift 2.0, ScanX Swift View 2.0 by Durr Dental SE — Product Code MUH

K230095 is an FDA 510(k) premarket notification submitted by Durr Dental SE for the device "ScanX Swift 2.0, ScanX Swift View 2.0". The FDA issued a decision of Substantially Equivalent on February 6, 2023. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Durr Dental SE has at least 8 other 510(k) clearances on record.