GenesisZr 4Y+ (ST1100) Zirconia

GenesisZr 4Y+ (ST1100) Zirconia is an FDA 510(k)-cleared medical device (K201915) manufactured by United Dental Resources Corporation. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2021. Regulation: 8.