EJK · Class II · 21 CFR 872.3250

FDA Product Code EJK: Liner, Cavity, Calcium Hydroxide

Leading manufacturers include Ultradent Products, Inc., Dentsply Intl. and Voco GmbH.

78
Total
78
Cleared
91d
Avg days
1976
Since
78 devices
49–72 of 78
Cleared Jun 28, 1991
VLC GLASS IONOMER LINER
K911244
Dentsply Intl.
Dental · 99d
Cleared Mar 15, 1991
IONOSEAL
K905723
Micro-Vac, Inc.
Dental · 85d
Cleared Feb 19, 1991
IONOBOND
K905724
Micro-Vac, Inc.
Dental · 61d
Cleared Nov 19, 1990
PHOTAC-BOND
K904096
Espe GmbH (Us)
Dental · 74d
Cleared Nov 09, 1990
PHOTAC-BOND APLICAP
K904097
Espe GmbH (Us)
Dental · 64d
Cleared Jul 31, 1990
FUJI LINING CEMENT LIGHT CURE
K901999
G-C Intl. Corp.
Dental · 90d
Cleared Mar 27, 1990
INTERFACE - CAVITY LINER
K897130
Scientific Pharmaceuticals, Inc.
Dental · 90d
Cleared Jan 16, 1990
BASIC CALCIUM HYDROXIDE LINER
K896529
Ivoclar North America, Inc.
Dental · 63d
Cleared Dec 08, 1989
CALASEPT PASTE
K895508
Js Dental Mfg., Inc.
Dental · 88d
Cleared Feb 23, 1989
VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER
K884949
Ortho Source
Dental · 90d
Cleared Jan 04, 1989
PERFECT CHOICE
K884245
Challenge Products, Inc.
Dental · 85d
Cleared Nov 29, 1988
GLASS IONOMER BASE
K882751
Dentsply Intl.
Dental · 147d
Cleared Feb 26, 1988
ALKALINER
K873882
Espe GmbH (Us)
Dental · 156d
Cleared Dec 16, 1987
PROTECT DROPS/SAME AS K874070
K874194
John O. Butler
Dental · 63d
Cleared Aug 26, 1987
KERR CAVALITE
K872147
Kerr Corporation (Danbury)
Dental · 83d
Cleared Dec 05, 1986
TUBULITEC LINER
K864053
Dental Dimensions Supply Co.
Dental · 50d
Cleared Jul 25, 1985
TUBULITEC LINER
K851053
Dental Therapeutics AB
Dental · 133d
Cleared Jul 13, 1984
KERR SEALAPEX ROOT CANAL SEALER
K841910
Sybron Corp.
Dental · 65d
Cleared Feb 27, 1984
HYDROXYLINE
K833640
George Taub Products & Fusion Co., Inc.
Dental · 133d
Cleared Jun 30, 1983
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575
Coe Laboratories, Inc.
Dental · 45d
Cleared Feb 18, 1983
HYDROL
K830112
North Pacific Dental, Inc.
Dental · 38d
Cleared Mar 23, 1982
IMPROVED DYCAL
K820215
Dentsply Intl.
Dental · 56d
Cleared Feb 23, 1981
ETCHING GEL
K810266
Espe-Premier Sales Co.
Dental · 21d
Cleared Nov 12, 1980
REOLIT
K802685
Vivadent (Usa), Inc.
Dental · 15d