510(k) K212932

Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray by Nobel Biocare Services AG — Product Code KCT

K212932 is an FDA 510(k) premarket notification submitted by Nobel Biocare Services AG for the device "Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray". The FDA issued a decision of Substantially Equivalent on December 18, 2021. 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 Services AG has at least 4 other 510(k) clearances on record.