510(k) K191475

Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate by Nobel Biocare AB — Product Code KCT

K191475 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate". The FDA issued a decision of Substantially Equivalent on August 29, 2019. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Nobel Biocare AB has at least 10 other 510(k) clearances on record.