510(k) K161444

DBSWIN and VistaEasy Imaging Software by Duerr Dental AG — Product Code LLZ

K161444 is an FDA 510(k) premarket notification submitted by Duerr Dental AG for the device "DBSWIN and VistaEasy Imaging Software". The FDA issued a decision of Substantially Equivalent on June 21, 2016. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Duerr Dental AG has at least 2 other 510(k) clearances on record.