510(k) K212125

Nobel Biocare Dental Implant Systems Portfolio - MR Conditional by Nobel Biocare AG — Product Code DZE

K212125 is an FDA 510(k) premarket notification submitted by Nobel Biocare AG for the device "Nobel Biocare Dental Implant Systems Portfolio - MR Conditional". The FDA issued a decision of Substantially Equivalent on September 24, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Nobel Biocare AG has at least 10 other 510(k) clearances on record.