510(k) K202344

TiUltra Implants and Xeal Abutments by Nobel Biocare AB — Product Code DZE

K202344 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "TiUltra Implants and Xeal Abutments". The FDA issued a decision of Substantially Equivalent on November 16, 2020. 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.