510(k) K252197

Nobel Biocare S Series Implants by Nobel Biocare AB — Product Code DZE

K252197 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "Nobel Biocare S Series Implants". The FDA issued a decision of Substantially Equivalent on February 18, 2026. 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.