510(k) K203116

SensorX by Durr Dental SE — Product Code MUH

K203116 is an FDA 510(k) premarket notification submitted by Durr Dental SE for the device "SensorX". The FDA issued a decision of Substantially Equivalent on March 19, 2021. 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.