KIF · Class II · 21 CFR 872.3820

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
49–72 of 144
Cleared Jan 11, 2019
MTA2.3 MATERIALS
K181917
NuSmile, Ltd.
Dental · 178d
Cleared Jan 04, 2019
BIO-C TEMP
K180199
Angelus Industria DE Produtos Odontologicos S/A
Dental · 345d
Cleared Oct 22, 2018
Sonendo Material A
K181922
Sonendo, Inc.
Dental · 96d
Cleared Aug 31, 2018
BIO-C REPAIR
K180185
Angelus Industria DE Produtos Odontologicos S/A
Dental · 220d
Cleared Feb 26, 2018
ENDOSEAL MTA
K170175
Maruchi
Dental · 403d
Cleared Feb 13, 2018
ENDOSOLV
K172839
Septodont
Dental · 147d
Cleared Jan 04, 2018
BIO-C SEALER
K172701
Angelus Industria DE Produtos Odontologicos S/A
Dental · 119d
Cleared Dec 20, 2017
Well-Root ST
K170950
Vericom Co., Ltd.
Dental · 264d
Cleared Jul 31, 2017
Obturys
K170207
Itena Clinical
Dental · 188d
Cleared Apr 25, 2017
SavDenTM MTA Root Canal Filling Materials
K162661
Tyds Biotech Incorporation
Dental · 211d
Cleared Sep 01, 2016
MTA2.2 MATERIAL
K161239
Avalon Biomed, Inc.
Dental · 122d
Cleared Aug 31, 2016
MTA Repair HP
K151047
Angelus Industria DE Productos Odontologicos
Dental · 499d
Cleared Jul 27, 2016
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K153067
Sybron Dental Specialties
Dental · 279d
Cleared May 06, 2016
Pulp Canal Sealer, Pulp Canal Sealer EWT
K152956
Sybron Dental Specialties
Dental · 212d
Cleared Apr 14, 2016
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
K152959
Sybron Dental Specialties
Dental · 190d
Cleared Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178
Dentsply International, Inc.
Dental · 202d
Cleared Sep 18, 2014
IROOT FM
K130312
Innovative Bioceramix, Inc.
Dental · 588d
Cleared Jun 27, 2014
BIODENTINE
K140132
Septodont
Dental · 161d
Cleared Jun 11, 2014
MTA2.1 MATERIAL
K140955
Avalon Biomed, Inc.
Dental · 58d
Cleared May 12, 2014
ENDOCEM ZR
K133042
Maruchi
Dental · 227d
Cleared May 12, 2014
ENDOSEAL
K133054
Maruchi
Dental · 227d
Cleared Apr 25, 2014
MTA FILLAPEX
K140247
Angelus Industria DE Productos Odontologicos SA
Dental · 85d
Cleared Apr 10, 2014
RETROMTA-ORTHOMTA II
K132825
Biomta
Dental · 213d
Cleared Apr 09, 2014
TRC-PASTE
K133716
Km Corporation
Dental · 125d