510(k) K162043

NobelProcera HT ML FCZ Bridge by Nobel Biocare AB — Product Code ELL

K162043 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "NobelProcera HT ML FCZ Bridge". The FDA issued a decision of Substantially Equivalent on November 22, 2016. 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.