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
Jan 11, 2019
MTA2.3 MATERIALS
NuSmile, Ltd.
Dental
178d
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
Dec 20, 2017
Well-Root ST
Vericom Co., Ltd.
Dental
264d
Cleared
Jul 31, 2017
Obturys
Itena Clinical
Dental
188d
Cleared
Apr 25, 2017
SavDenTM MTA Root Canal Filling Materials
Tyds Biotech Incorporation
Dental
211d
Cleared
Sep 01, 2016
MTA2.2 MATERIAL
Avalon Biomed, Inc.
Dental
122d
Cleared
Aug 31, 2016
MTA Repair HP
Angelus Industria DE Productos Odontologicos
Dental
499d
Cleared
Jul 27, 2016
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
Sybron Dental Specialties
Dental
279d
Cleared
May 06, 2016
Pulp Canal Sealer, Pulp Canal Sealer EWT
Sybron Dental Specialties
Dental
212d
Cleared
Apr 14, 2016
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
Sybron Dental Specialties
Dental
190d
Cleared
Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
Dentsply International, Inc.
Dental
202d
Cleared
Sep 18, 2014
IROOT FM
Innovative Bioceramix, Inc.
Dental
588d
Cleared
Jun 27, 2014
BIODENTINE
Septodont
Dental
161d
Cleared
Jun 11, 2014
MTA2.1 MATERIAL
Avalon Biomed, Inc.
Dental
58d
Cleared
May 12, 2014
ENDOCEM ZR
Maruchi
Dental
227d
Cleared
May 12, 2014
ENDOSEAL
Maruchi
Dental
227d
Cleared
Apr 25, 2014
MTA FILLAPEX
Angelus Industria DE Productos Odontologicos SA
Dental
85d
Cleared
Apr 10, 2014
RETROMTA-ORTHOMTA II
Biomta
Dental
213d
Cleared
Apr 09, 2014
TRC-PASTE
Km Corporation
Dental
125d