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 Prismatik Dentalcraft, Inc., Voco GmbH and Dentsply Sirona.
List of Resin, Denture, Relining, Repairing, Rebasing devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Resin, Denture, Relining, Repairing, Rebasing devices (product code EBI). 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 →