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 Shofu Dental Corporation, Cosmedent, Inc. and Ultradent Products, Inc..
List of Material, Tooth Shade, Resin devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Material, Tooth Shade, Resin devices (product code EBF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →