PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS

PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS is an FDA 510(k)-cleared medical device (K872272) manufactured by Columbus Dental Mfg. Co.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 1987. Regulation: 8.