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 Aidite (Qinhuangdao) Technology Co., Ltd..
FDA 510(k) Cleared Resin, Denture, Relining, Repairing, Rebasing Devices (Product Code EBI)
About Product Code EBI - Regulatory Context
510(k) Submission Activity
328 total 510(k) submissions under product code EBI since 1978, with 328 receiving FDA clearance (average review time: 105 days).
Submission volume has remained relatively stable over the observed period, with 18 submissions in the last 24 months.
FDA Review Time
FDA review times for EBI submissions have been consistent, averaging 101 days recently vs 106 days historically.
EBI devices are reviewed by the Dental panel. Browse all Dental devices →