SEPTOSIL SILICONE FOR PRECISION IMPRESSION

SEPTOSIL SILICONE FOR PRECISION IMPRESSION is an FDA 510(k)-cleared medical device (K851388) manufactured by Specialites Septodont. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 1985. Regulation: 8.