EBZ · Class II · 21 CFR 872.6070

FDA Product Code EBZ: Activator, Ultraviolet, For Polymerization

Leading manufacturers include Ultradent Products, Inc., Ivoclar Vivadent, Inc. and Monitex Industrial Co., Ltd..

214
Total
214
Cleared
95d
Avg days
1977
Since
214 devices
121–144 of 214
Cleared May 24, 1995
COLTOLUX LIGHT METER
K950106
Coltene/Whaledent, Inc.
Dental · 133d
Cleared May 05, 1995
SPECTRUM CURING LIGHT POLYMERIZATION UNIT
K951425
Dentsply Intl.
Dental · 39d
Cleared Jan 06, 1994
3M CURING LIGHT XL1500
K934746
3M Company
Dental · 94d
Cleared Apr 23, 1993
ORTHOLUX XT
K930086
3M Company
Dental · 106d
Cleared Nov 25, 1992
3M CURING LIGHT XL 3000
K924812
3M Company
Dental · 61d
Cleared Dec 16, 1991
HELIOLUX
K913980
Ivoclar North America, Inc.
Dental · 101d
Cleared Mar 15, 1991
SPECTRAMAT
K910068
Ivoclar North America, Inc.
Dental · 65d
Cleared Jul 13, 1990
HELIOLUX VISIBLE CURING LIGHT
K901908
Ivoclar North America, Inc.
Dental · 78d
Cleared Aug 21, 1989
TULUX-FILTER
K892517
Espe GmbH (Us)
Dental · 132d
Cleared Jun 14, 1989
KULZER TRANSLUX EC
K892456
Kulzer, Inc.
Dental · 65d
Cleared Sep 06, 1988
PHOTO-CURING LIGHT
K882145
Dentsply Intl.
Dental · 106d
Cleared Apr 07, 1988
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392
Unitek Corp.
Dental · 69d
Cleared Mar 26, 1986
OP II VISIBLE LIGHT CURING SYSTEM
K854696
Almore Intl., Inc.
Dental · 125d
Cleared Dec 11, 1984
COE-LITE POLYMERIZATION UNIT
K844325
Coe Laboratories, Inc.
Dental · 34d
Cleared Dec 04, 1984
TRANSLUX CL
K843823
Kulzer, Inc.
Dental · 67d
Cleared Aug 31, 1983
PRISMA III
K832320
Dentsply Intl.
Dental · 47d
Cleared Jul 28, 1981
KULZER TRANSLUX VISIBLE LIGHT CURING
K811668
Kulzer, Inc.
Dental · 43d
Cleared Sep 16, 1980
CAULK PRISMA-LITE
K801588
Dentsply Intl.
Dental · 67d
Cleared Jan 03, 1978
FOTOFILL ACTIVATOR LIGHT
K772278
Johnson & Johnson Professionals, Inc.
Dental · 22d
Cleared Jun 24, 1977
ULTRAVIOLET RAD-EMITTING LAMP
K771077
Lee Pharmaceuticals
Dental · 9d
Cleared Apr 05, 1977
NUVA-LITE II PHOTO-CURE UNIT
K770599
Dentsply Intl.
Dental · 7d
Cleared Jan 28, 1977
ESTILUX UV SYSTEM
K770113
Degussa Dental, Inc.
Dental · 9d