FDA Product Code EBF: Material, Tooth Shade, Resin

Under FDA product code EBF, tooth-shade resin materials are cleared for use in direct and indirect dental restorations.

These composite resins are formulated to match the natural color and translucency of tooth structure, enabling esthetic restorations in both anterior and posterior teeth. Modern formulations offer high radiopacity, low polymerization shrinkage, and wear resistance comparable to amalgam.

EBF devices are Class II medical devices, regulated under 21 CFR 872.3690 and reviewed by the FDA Dental panel.

Leading manufacturers include Mediclus Co., Ltd., Aidite (Qinhuangdao) Technology Co., Ltd. and Voco GmbH.