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 Ultradent Products, Inc..
143
Total
143
Cleared
135d
Avg days
1977
Since
143 devices
Cleared
Jan 04, 2019
BIO-C TEMP
Angelus Industria DE Produtos Odontologicos S/A
Dental
345d
Cleared
Oct 22, 2018
Sonendo Material A
Sonendo, Inc.
Dental
96d
Cleared
Aug 31, 2018
BIO-C REPAIR
Angelus Industria DE Produtos Odontologicos S/A
Dental
220d
Cleared
Feb 26, 2018
ENDOSEAL MTA
Maruchi
Dental
403d
Cleared
Feb 13, 2018
ENDOSOLV
Septodont
Dental
147d
Cleared
Jan 04, 2018
BIO-C SEALER
Angelus Industria DE Produtos Odontologicos S/A
Dental
119d
Cleared
Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
Dentsply International, Inc.
Dental
202d
Cleared
May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
Ultradent Products, Inc.
Dental
19d
Cleared
Jun 15, 2006
CZ-S2000
Parkell, Inc.
Dental
70d
Cleared
Oct 26, 2004
ENDOREZ
Ultradent Products, Inc.
Dental
22d
Cleared
Jan 16, 2004
DIAPEX
Bisco, Inc.
Dental
64d
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
Cleared
Oct 26, 1999
ENDOREZ
Ultradent Products, Inc.
Dental
127d
Cleared
Jul 31, 1998
MTA MATERIAL II
Dentsply Intl.
Dental
86d
Cleared
Feb 24, 1998
MTA MATERIAL
Dentsply Intl.
Dental
27d
Cleared
Aug 15, 1997
SEALAPEX
Sybron Dental Specialties, Inc.
Dental
51d
Cleared
Jun 26, 1997
ENDO-SEAL
Ultradent Products, Inc.
Dental
35d
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
Sep 20, 1993
PULPDENT EDTA PREPARATIONS
Pulpdent Corp.
Dental
103d
Cleared
Feb 14, 1990
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
Pulpdent Corp.
Dental
82d