EJK · Class II · 21 CFR 872.3250

FDA Product Code EJK: Liner, Cavity, Calcium Hydroxide

Leading manufacturers include Ultradent Products, Inc., Voco GmbH and Centrix, Inc..

78
Total
78
Cleared
91d
Avg days
1976
Since
78 devices
25–48 of 78
Cleared Oct 30, 1997
ROEKO CALCIUM HYDROXIDE POINTS
K973539
Roeko USA, Inc.
Dental · 42d
Cleared Apr 02, 1997
ULTRA-BLEND PLUS
K970113
Ultradent Products, Inc.
Dental · 79d
Cleared Mar 14, 1997
ULTRACAL XS
K970114
Ultradent Products, Inc.
Dental · 60d
Cleared Jan 22, 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191
Sybron Dental Specialties, Inc.
Dental · 93d
Cleared May 30, 1996
LIFE AND LIFE FAST SET
K961708
Sybron Dental Specialties, Inc.
Dental · 28d
Cleared Aug 24, 1995
ULTRA-BLEND
K953524
Ultradent Products, Inc.
Dental · 28d
Cleared Aug 07, 1995
LIMELIGHT
K953079
Pulpdent Corp.
Dental · 35d
Cleared Nov 30, 1994
PULPDENT CALCIUM HYDROXIDE PREPARATIONS
K944945
Pulpdent Corp.
Dental · 54d
Cleared Nov 29, 1994
LIFE
K944416
Sybron Dental Specialties, Inc.
Dental · 78d
Cleared Sep 19, 1994
CALCIUM HYDROXIDE PASTE
K943372
Ultradent Products, Inc.
Dental · 68d
Cleared Jan 18, 1994
NEEDLETUBE SYRINGE CARTRTIDGE
K933507
Centrix, Inc.
Dental · 187d
Cleared Jan 05, 1994
STERIBASE (ACCUBASE)
K933999
Centrix, Inc.
Dental · 141d
Cleared Jul 22, 1993
VIVAGLASS LINER
K931502
Ivoclar North America, Inc.
Dental · 119d
Cleared Mar 31, 1993
CALCICUR
K926419
Voco GmbH
Dental · 98d
Cleared Nov 24, 1992
LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE
K921408
Ultradent Products, Inc.
Dental · 245d
Cleared Oct 16, 1992
CALCIMOL LC
K924182
Voco GmbH
Dental · 58d
Cleared Sep 28, 1992
CALCIMOL
K923849
Voco GmbH
Dental · 59d
Cleared Jul 23, 1992
VLC DYCAL II
K922721
Dentsply Intl.
Dental · 48d
Cleared Apr 21, 1992
SEPTOCALCINE ULTRA
K920692
Specialites Septodont
Dental · 67d
Cleared Sep 30, 1991
SEPTOCAL CAVITY LINER
K913574
Specialites Septodont
Dental · 49d
Cleared Jul 30, 1991
IONOSEAL
K912495
Voco GmbH
Dental · 55d
Cleared Jun 28, 1991
VLC GLASS IONOMER LINER
K911244
Dentsply Intl.
Dental · 99d
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