510(k) K211109

N1 TiUltra TCC Implant System by Nobel Biocare Services AG — Product Code DZE

K211109 is an FDA 510(k) premarket notification submitted by Nobel Biocare Services AG for the device "N1 TiUltra TCC Implant System". The FDA issued a decision of Substantially Equivalent on December 21, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Nobel Biocare Services AG has at least 4 other 510(k) clearances on record.