Identic and KromaFaze Alginate Dental Impression Materials

Identic and KromaFaze Alginate Dental Impression Materials is an FDA 510(k)-cleared medical device (K160441) manufactured by Kerr 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 June 29, 2016. Regulation: 8.