510(k) K200858

Mini Sterilizable Tray by Implant Direct Sybron Manufacturing, LLC — Product Code KCT

K200858 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "Mini Sterilizable Tray". The FDA issued a decision of Substantially Equivalent on August 6, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Implant Direct Sybron Manufacturing, LLC has at least 10 other 510(k) clearances on record.