510(k) K253988

LiteSet Trays by Nobel Biocare AB — Product Code KCT

K253988 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "LiteSet Trays". The FDA issued a decision of Substantially Equivalent on September 8, 2026. 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.