510(k) K183069

NobelZygoma 0° by Nobel Biocare AB — Product Code DZE

K183069 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "NobelZygoma 0°". The FDA issued a decision of Substantially Equivalent on December 4, 2018. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Nobel Biocare AB has at least 10 other 510(k) clearances on record.