510(k) K071182

PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 by Nobel Biocare AB — Product Code ELL

K071182 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013". The FDA issued a decision of Substantially Equivalent on July 11, 2007. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Nobel Biocare AB has at least 10 other 510(k) clearances on record.