510(k) K212068

Biotech Dental Kits by Biotech Dental, Sas — Product Code KCT

K212068 is an FDA 510(k) premarket notification submitted by Biotech Dental, Sas for the device "Biotech Dental Kits". The FDA issued a decision of Substantially Equivalent on November 8, 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. Biotech Dental, Sas has at least 3 other 510(k) clearances on record.