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., Maruchi and DiaDent Group International.
144
Total
144
Cleared
135d
Avg days
1977
Since
144 devices
Cleared
Dec 16, 1985
ROOT CANAL FILLING RESIN
Dentsply Intl.
Dental
55d
Cleared
Mar 19, 1982
ROOT CANAL FILLING RESIN
Dentsply Intl.
Dental
45d
Cleared
Apr 21, 1981
LEE ENDOFILL, ROOT CANAL FILLING RESIN
Lee Pharmaceuticals
Dental
15d
Cleared
Jul 21, 1980
HYDRON ROOT CANAL FILLING MATERIAL
National Patent Development Corp.
Dental
66d
Cleared
Nov 15, 1977
HYDRON ROOT CANAL FILLING SYSTEM
National Patent Development Corp.
Dental
34d