FDA Product Code EMA: Cement, Dental

FDA product code EMA covers dental cements used for the luting of restorations and the cementation of crowns, bridges, and orthodontic appliances.

These materials form a stable bond between tooth structure and restorative materials, sealing the margin against bacterial ingress and providing mechanical retention. Available formulations include resin, glass ionomer, zinc phosphate, and resin-modified glass ionomer cements.

EMA devices are Class II medical devices, regulated under 21 CFR 872.3275 and reviewed by the FDA Dental panel.

Leading manufacturers include Shofu Dental Corporation, Rizhao Huge Biomaterials Company, Ltd. and Voco GmbH.