3M RelyX Pediatric Resin Modified Glass Ionomer Cement

3M RelyX Pediatric Resin Modified Glass Ionomer Cement is an FDA 510(k)-cleared medical device (K191122) 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 28, 2019. Regulation: 8.