510(k) K262084

S.I.N. Instruments Kits by S.I.N. Implant System Ltda — Product Code KCT

K262084 is an FDA 510(k) premarket notification submitted by S.I.N. Implant System Ltda for the device "S.I.N. Instruments Kits". The FDA issued a decision of Substantially Equivalent on Oct 22, 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. S.I.N. Implant System Ltda has 4 other 510(k) clearances on record.