ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2

ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 is an FDA 510(k)-cleared medical device (K121824) manufactured by Lascod Spa. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2012. Regulation: 8.