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.
FDA 510(k) Cleared Material, Tooth Shade, Resin Devices (Product Code EBF)
About Product Code EBF - Regulatory Context
510(k) Submission Activity
927 total 510(k) submissions under product code EBF since 1976, with 927 receiving FDA clearance (average review time: 88 days).
Submission volume has increased in recent years - 36 submissions in the last 24 months compared to 28 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EBF have taken an average of 102 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.
EBF devices are reviewed by the Dental panel. Browse all Dental devices →