510(k) K222604

dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S by Dentona AG — Product Code MQC

K222604 is an FDA 510(k) premarket notification submitted by Dentona AG for the device "dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S". The FDA issued a decision of Substantially Equivalent on April 21, 2023. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.