
3M Espe Dental Products
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GILB-2, GLASS IONOMER PROTECTIVE COATING is an FDA 510(k)-cleared medical device (K073395) 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 January 16, 2008. Regulation: 8.