FDA Product Code EBI: Resin, Denture, Relining, Repairing, Rebasing

FDA product code EBI covers denture relining, repairing, and rebasing resins used to restore or modify the fit of existing dentures.

These acrylic resin materials are used to add new base material to a worn or ill-fitting denture — compensating for bone resorption that occurs after tooth extraction — or to repair fractures in existing prostheses. They are available for chairside or laboratory application.

EBI devices are Class II medical devices, regulated under 21 CFR 872.3760 and reviewed by the FDA Dental panel.

Leading manufacturers include Dentsply Intl., GC America, Inc. and Heraeus Kulzer, Inc..