510(k) K261935

Surgical and Prosthetic Trays by Dentsply Sirona, Inc. — Product Code KCT

K261935 is an FDA 510(k) premarket notification submitted by Dentsply Sirona, Inc. for the device "Surgical and Prosthetic Trays". The FDA issued a decision of Substantially Equivalent on September 4, 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. Dentsply Sirona, Inc. has at least 10 other 510(k) clearances on record.