510(k) K032562

PROCEARA COPINGS AND PONTIC by Nobel Biocare AB — Product Code ELL

K032562 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "PROCEARA COPINGS AND PONTIC". The FDA issued a decision of Substantially Equivalent on February 6, 2004. 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.