510(k) K243834

NobelZygoma TiUltra Implant system by Nobel Biocare AB — Product Code DZE

K243834 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "NobelZygoma TiUltra Implant system". The FDA issued a decision of Substantially Equivalent on August 25, 2025. 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.