FDA Product Code KIF: Resin, Root Canal Filling
FDA product code KIF covers root canal filling resins used in endodontic treatment.
These materials are used to obturate and seal the root canal system after pulp removal, preventing bacterial recontamination of the treated canal. Modern resin-based sealers bond to both dentin and the core filling material, improving the hermetic seal of the root canal filling.
KIF devices are Class II medical devices, regulated under 21 CFR 872.3820 and reviewed by the FDA Dental panel.
Leading manufacturers include Meta Biomed Co., Ltd., Ultradent Products, Inc. and Dentsply Sirona, Inc..
List of Resin, Root Canal Filling devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Resin, Root Canal Filling devices (product code KIF). 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 →