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