HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400

HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 is an FDA 510(k)-cleared medical device (K992609) manufactured by Kay See Dental Mfg. Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 1999. Regulation: 8.