EDS Calculus Softener TURBO CR

EDS Calculus Softener TURBO CR is an FDA 510(k)-cleared medical device (K223340) manufactured by Essential Dental Systems, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2023. Regulation: 8.