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
Mar 20, 2014
TRC-PEX, RADIC-SEALER
Km Corporation
Dental
253d
Cleared
Mar 10, 2014
MM-SEAL
Micro-Mega Societe Anonyme
Dental
507d
Cleared
Oct 17, 2013
BIOROOT RCS
Novocol, Inc.
Dental
224d
Cleared
Jul 24, 2013
MTA CEMENTS
S&C Polymer Silicon- Und Composite Spezialitaeten
Dental
188d
Cleared
Dec 11, 2012
MTA2 ROOT AND PULP MATERIALS
Avalon Biomed, Inc.
Dental
82d
Cleared
Aug 21, 2012
MTA-FILLAPEX
Paxmed International
Dental
263d
Cleared
Jun 20, 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
Drfp , Ltd.
Dental
166d
Cleared
Mar 19, 2012
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
Maruchi
Dental
242d
Cleared
Jan 06, 2012
MTA ANGELUS
Angelus Industria DE Productos Odontologicos
Dental
172d
Cleared
Oct 16, 2010
REALSEAL XT SEALER
Kerr Corporation
Dental
75d
Cleared
Apr 21, 2009
WELL-PASTE
Vericom Co., Ltd.
Dental
14d
Cleared
Mar 12, 2009
ROOT CANAL XR
S & C Polymer GmbH
Dental
149d
Cleared
Feb 06, 2008
WELL-PEX
Vericom Co., Ltd.
Dental
5d
Cleared
May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
Ultradent Products, Inc.
Dental
19d
Cleared
Feb 06, 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
Essential Dental Systems, Inc.
Dental
40d
Cleared
Jun 15, 2006
CZ-S2000
Parkell, Inc.
Dental
70d
Cleared
Nov 24, 2004
ADSEAL ROOT CANAL SEALER
Meta Biomed Co., Ltd.
Dental
50d
Cleared
Oct 26, 2004
ENDOREZ
Ultradent Products, Inc.
Dental
22d
Cleared
Jan 16, 2004
DIAPEX
Bisco, Inc.
Dental
64d
Cleared
Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
Meta Biomed Co., Ltd.
Dental
44d
Cleared
Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
Meta Biomed Co., Ltd.
Dental
43d
Cleared
Oct 07, 2002
PULPDENT CALCIUM HYDROXIDE PREPARATION
Pulpdent Corporation
Dental
52d
Cleared
Aug 03, 2001
FIRST FILL R.C.S.
Jeneric/Pentron, Inc.
Dental
58d
Cleared
Jun 20, 2001
SEALAPEX 4
Sybron Dental Specialties, Inc.
Dental
83d