RELYX LUTING PLUS AUTOMIX

RELYX LUTING PLUS AUTOMIX is an FDA 510(k)-cleared medical device (K111185) manufactured by 3M Espe Dental Products. 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 4, 2011. Regulation: 8.