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