510(k) K203156

DTX Studio Clinic by Nobel Biocare AB — Product Code LLZ

K203156 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "DTX Studio Clinic". The FDA issued a decision of Substantially Equivalent on November 20, 2020. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Nobel Biocare AB has at least 10 other 510(k) clearances on record.