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 Mediclus Co., Ltd., Meta Biomed Co., Ltd. and Enpuno Biotechnology Co., Ltd..
FDA 510(k) Cleared Resin, Root Canal Filling Devices (Product Code KIF)
About Product Code KIF - Regulatory Context
510(k) Submission Activity
143 total 510(k) submissions under product code KIF since 1977, with 143 receiving FDA clearance (average review time: 135 days).
Submission volume has increased in recent years - 15 submissions in the last 24 months compared to 12 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KIF have taken an average of 98 days to reach a decision - down from 139 days historically, suggesting improved FDA processing for this classification.
KIF devices are reviewed by the Dental panel. Browse all Dental devices →