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 DiaDent Group International, Meta Biomed Co., Ltd. and Dentsply Intl..

143
Total
143
Cleared
135d
Avg days
1977
Since
143 devices
25–48 of 143
Cleared Nov 22, 2022
iRoot BP Root Repair Material BioAggregate Paste
K222992
Innovative Bioceramix, Inc.
Dental · 55d
Cleared Nov 21, 2022
Vista BC Sealer
K221811
Inter-Med, Inc.
Dental · 152d
Cleared May 23, 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
K212563
Prevest Denpro Limited
Dental · 283d
Cleared Dec 08, 2021
Injectable Root Canal Bioceramic Sealer
K212983
Beijing C-Root Dental Medical Devices Co., Ltd.
Dental · 82d
Cleared Oct 13, 2021
UltraCal XS
K211905
Ultradent Products, Inc.
Dental · 114d
Cleared Sep 16, 2021
BioRoot Flow 0.5g, BioRoot Flow 2g
K212283
Septodont
Dental · 57d
Cleared Aug 27, 2021
Sonendo Filling Material 5C
K211995
Sonendo, Inc.
Dental · 60d
Cleared Aug 13, 2021
White Endoseal MTA
K212229
Maruchi
Dental · 28d
Cleared Aug 10, 2021
Biodentine XP 500, Biodentine XP 200
K211799
Septodont
Dental · 61d
Cleared Jun 30, 2021
Metapaste Plus
K210904
Meta Biomed Co., Ltd.
Dental · 96d
Cleared Apr 14, 2021
Metapex Plus
K202617
Meta Biomed Co., Ltd.
Dental · 217d
Cleared Mar 25, 2021
DiaPaste
K210333
DiaDent Group International
Dental · 48d
Cleared Mar 24, 2021
White ENDOSEAL MTA
K202015
Maruchi
Dental · 246d
Cleared Feb 12, 2021
EDS Bioceramic Sealer (Bioseal)
K202281
Essential Dental Systems
Dental · 184d
Cleared Feb 11, 2021
Bio-C Repair Ion+
K201222
Angelus Industria DE Produtos Odontologicos S/A
Dental · 281d
Cleared Sep 18, 2020
DIA-ROOT BIO MTA
K200174
DiaDent Group International
Dental · 239d
Cleared Jun 25, 2020
DIA-ROOT BIO Sealer
K200175
DiaDent Group International
Dental · 154d
Cleared Mar 27, 2020
Diapaste
K190091
DiaDent Group International
Dental · 434d
Cleared Dec 12, 2019
BIO-C Sealer Ion+
K190537
Angelus Industria DE Produtos Odontologicos S/A
Dental · 283d
Cleared Sep 26, 2019
Dia-Proseal
K182009
DiaDent Group International
Dental · 426d
Cleared Jun 07, 2019
CeraSeal
K190503
Meta Biomed Co., Ltd.
Dental · 98d
Cleared Jun 03, 2019
Diapex Plus
K182625
DiaDent Group International
Dental · 252d
Cleared May 29, 2019
GuttaSil
K190510
Meta Biomed Co., Ltd.
Dental · 89d
Cleared Jan 11, 2019
MTA2.3 MATERIALS
K181917
NuSmile, Ltd.
Dental · 178d