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 DiaDent Group International, Meta Biomed Co., Ltd. and Dentsply Intl..
143
Total
143
Cleared
135d
Avg days
1977
Since
143 devices
Cleared
Jan 04, 2019
BIO-C TEMP
Angelus Industria DE Produtos Odontologicos S/A
Dental
345d
Cleared
Oct 22, 2018
Sonendo Material A
Sonendo, Inc.
Dental
96d
Cleared
Aug 31, 2018
BIO-C REPAIR
Angelus Industria DE Produtos Odontologicos S/A
Dental
220d
Cleared
Feb 26, 2018
ENDOSEAL MTA
Maruchi
Dental
403d
Cleared
Feb 13, 2018
ENDOSOLV
Septodont
Dental
147d
Cleared
Jan 04, 2018
BIO-C SEALER
Angelus Industria DE Produtos Odontologicos S/A
Dental
119d
Cleared
Jul 31, 1998
MTA MATERIAL II
Dentsply Intl.
Dental
86d
Cleared
Feb 24, 1998
MTA MATERIAL
Dentsply Intl.
Dental
27d
Cleared
Apr 26, 1996
AH PLUS ROOT CANAL SEALER
Dentsply Intl.
Dental
78d
Cleared
Dec 16, 1985
ROOT CANAL FILLING RESIN
Dentsply Intl.
Dental
55d
Cleared
Mar 19, 1982
ROOT CANAL FILLING RESIN
Dentsply Intl.
Dental
45d