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
73–96 of 144
Cleared Mar 20, 2014
TRC-PEX, RADIC-SEALER
K132123
Km Corporation
Dental · 253d
Cleared Mar 10, 2014
MM-SEAL
K123276
Micro-Mega Societe Anonyme
Dental · 507d
Cleared Oct 17, 2013
BIOROOT RCS
K130601
Novocol, Inc.
Dental · 224d
Cleared Jul 24, 2013
MTA CEMENTS
K130125
S&C Polymer Silicon- Und Composite Spezialitaeten
Dental · 188d
Cleared Dec 11, 2012
MTA2 ROOT AND PULP MATERIALS
K122892
Avalon Biomed, Inc.
Dental · 82d
Cleared Aug 21, 2012
MTA-FILLAPEX
K113568
Paxmed International
Dental · 263d
Cleared Jun 20, 2012
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048
Drfp , Ltd.
Dental · 166d
Cleared Mar 19, 2012
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K112078
Maruchi
Dental · 242d
Cleared Jan 06, 2012
MTA ANGELUS
K112046
Angelus Industria DE Productos Odontologicos
Dental · 172d
Cleared Oct 16, 2010
REALSEAL XT SEALER
K102163
Kerr Corporation
Dental · 75d
Cleared Apr 21, 2009
WELL-PASTE
K090992
Vericom Co., Ltd.
Dental · 14d
Cleared Mar 12, 2009
ROOT CANAL XR
K083062
S & C Polymer GmbH
Dental · 149d
Cleared Feb 06, 2008
WELL-PEX
K080266
Vericom Co., Ltd.
Dental · 5d
Cleared May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106
Ultradent Products, Inc.
Dental · 19d
Cleared Feb 06, 2007
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
K063856
Essential Dental Systems, Inc.
Dental · 40d
Cleared Jun 15, 2006
CZ-S2000
K060946
Parkell, Inc.
Dental · 70d
Cleared Nov 24, 2004
ADSEAL ROOT CANAL SEALER
K042769
Meta Biomed Co., Ltd.
Dental · 50d
Cleared Oct 26, 2004
ENDOREZ
K042756
Ultradent Products, Inc.
Dental · 22d
Cleared Jan 16, 2004
DIAPEX
K033585
Bisco, Inc.
Dental · 64d
Cleared Oct 08, 2003
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605
Meta Biomed Co., Ltd.
Dental · 44d
Cleared Oct 07, 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603
Meta Biomed Co., Ltd.
Dental · 43d
Cleared Oct 07, 2002
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734
Pulpdent Corporation
Dental · 52d
Cleared Aug 03, 2001
FIRST FILL R.C.S.
K011748
Jeneric/Pentron, Inc.
Dental · 58d
Cleared Jun 20, 2001
SEALAPEX 4
K010940
Sybron Dental Specialties, Inc.
Dental · 83d