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 DiaDent Group International, Meta Biomed Co., Ltd. and Ultradent Products, Inc..

143
Total
143
Cleared
135d
Avg days
1977
Since
143 devices
49–72 of 143
Cleared Jan 04, 2019
BIO-C TEMP
K180199
Angelus Industria DE Produtos Odontologicos S/A
Dental · 345d
Cleared Oct 22, 2018
Sonendo Material A
K181922
Sonendo, Inc.
Dental · 96d
Cleared Aug 31, 2018
BIO-C REPAIR
K180185
Angelus Industria DE Produtos Odontologicos S/A
Dental · 220d
Cleared Feb 26, 2018
ENDOSEAL MTA
K170175
Maruchi
Dental · 403d
Cleared Feb 13, 2018
ENDOSOLV
K172839
Septodont
Dental · 147d
Cleared Jan 04, 2018
BIO-C SEALER
K172701
Angelus Industria DE Produtos Odontologicos S/A
Dental · 119d
Cleared Feb 26, 2015
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178
Dentsply International, Inc.
Dental · 202d
Cleared May 08, 2007
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
K071106
Ultradent Products, Inc.
Dental · 19d
Cleared Jun 15, 2006
CZ-S2000
K060946
Parkell, Inc.
Dental · 70d
Cleared Oct 26, 2004
ENDOREZ
K042756
Ultradent Products, Inc.
Dental · 22d
Cleared Jan 16, 2004
DIAPEX
K033585
Bisco, Inc.
Dental · 64d
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
Cleared Oct 26, 1999
ENDOREZ
K992097
Ultradent Products, Inc.
Dental · 127d
Cleared Jul 31, 1998
MTA MATERIAL II
K981620
Dentsply Intl.
Dental · 86d
Cleared Feb 24, 1998
MTA MATERIAL
K980332
Dentsply Intl.
Dental · 27d
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 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 Sep 20, 1993
PULPDENT EDTA PREPARATIONS
K932791
Pulpdent Corp.
Dental · 103d
Cleared Feb 14, 1990
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656
Pulpdent Corp.
Dental · 82d