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
97–120 of 144
Cleared May 02, 2001
WHITE MTA MATERIAL
K011009
Dentsply International
Dental · 28d
Cleared Jan 18, 2000
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
K992727
Mds
Dental · 158d
Cleared Oct 26, 1999
ENDOREZ
K992097
Ultradent Products, Inc.
Dental · 127d
Cleared Oct 20, 1998
ROEKO SEAL
K983037
Roeko Ulm, Roescheisen GmbH & Co.
Dental · 50d
Cleared Jul 31, 1998
MTA MATERIAL II
K981620
Dentsply Intl.
Dental · 86d
Cleared May 01, 1998
ENDOSOLV E
K980633
Specialites Septodont
Dental · 71d
Cleared Feb 24, 1998
MTA MATERIAL
K980332
Dentsply Intl.
Dental · 27d
Cleared Nov 06, 1997
VITAPEX PRE-LOADED DENTAL SYRINGE
K973667
Neodental Chemical Products Co., Ltd.
Dental · 42d
Cleared Aug 15, 1997
SEALAPEX
K972369
Sybron Dental Specialties, Inc.
Dental · 51d
Cleared Jun 26, 1997
ENDO-SEAL
K971899
Ultradent Products, Inc.
Dental · 35d
Cleared Jun 20, 1997
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
K971622
Mpl Technologies, Inc.
Dental · 49d
Cleared Feb 10, 1997
MINERAL TRIOXIDE AGGREGATE (MTA)
K964174
Tulsa Dental Products, Ltd.
Dental · 115d
Cleared Dec 06, 1996
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922
Wallace A. Erickson & Co.
Dental · 67d
Cleared Aug 30, 1996
SEALEX EXTRA ROOT CANAL SEALER
K962885
Baladent
Dental · 37d
Cleared May 20, 1996
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
K955703
Neodental Chemical Products Co., Ltd.
Dental · 158d
Cleared Apr 26, 1996
AH PLUS ROOT CANAL SEALER
K960548
Dentsply Intl.
Dental · 78d
Cleared Jan 20, 1995
CANAL KING (THIN) CANAL KING (THICK)
K940368
Pulpdent Corp.
Dental · 359d
Cleared Jan 20, 1995
PULPDENT ROOT CANAL SEALER
K946138
Pulpdent Corp.
Dental · 35d
Cleared Jun 10, 1994
TUBLI-SEAL EWT
K942393
Sybron Dental Specialties, Inc.
Dental · 22d
Cleared Feb 01, 1994
ALPHA-DENT ROOT CANAL SEALER
K930872
Wallace A. Erickson & Co.
Dental · 347d
Cleared Sep 20, 1993
PULPDENT EDTA PREPARATIONS
K932791
Pulpdent Corp.
Dental · 103d
Cleared Mar 09, 1992
ROOT CANAL FILLING CEMENT
K914325
Confi-Dental Products Co.
Dental · 165d
Cleared Feb 14, 1990
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656
Pulpdent Corp.
Dental · 82d
Cleared Feb 14, 1990
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K896657
Pulpdent Corp.
Dental · 82d