SOFT DENTURE RELINE MATERIAL ELASTOLINE

SOFT DENTURE RELINE MATERIAL ELASTOLINE is an FDA 510(k)-cleared medical device (K925275) manufactured by Great Lakes Orthodontics, Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1993. Regulation: 8.