MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL

MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL is an FDA 510(k)-cleared medical device (K905032) manufactured by Parkell. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1991. Regulation: 8.