510(k) K213326

VisionX 3.0 by Durr Dental SE — Product Code LLZ

K213326 is an FDA 510(k) premarket notification submitted by Durr Dental SE for the device "VisionX 3.0". The FDA issued a decision of Substantially Equivalent on November 2, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Durr Dental SE has at least 8 other 510(k) clearances on record.