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
97–120 of 214
Cleared Jan 13, 2000
PORTABLE LIGHT CURING UNIT
K994048
Gregory S. Jacob, D.D.S.
Dental · 48d
Cleared Jan 12, 2000
FLIPO XENON CURING LIGHT
K994028
Lokki
Dental · 47d
Cleared Nov 01, 1999
RAPICURE 200 (CURING AND WHITENING LIGHT)
K993223
Mediphotonix, LC
Dental · 35d
Cleared Sep 29, 1999
SPRING POWERLITE 2000
K992728
Spring Health Products, Inc.
Dental · 47d
Cleared Aug 30, 1999
EASY-CURE (CURING AND WHITENING LIGHT)
K992357
Ics of North America, Inc.
Dental · 47d
Cleared Aug 27, 1999
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
K992236
Lysta A/S
Dental · 56d
Cleared Jul 20, 1999
Q-LITE 75 LIGHT CURE UNIT
K991865
Rolence Enterprise Co. , Ltd.
Dental · 49d
Cleared Jul 19, 1999
CUTE-LITE I LIGHT CURE UNIT
K991863
Rolence Enterprise Co. , Ltd.
Dental · 48d
Cleared Apr 23, 1999
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K991138
Lysta A/S
Dental · 18d
Cleared Feb 25, 1999
ELIPAR TRILIGHT
K984247
Espe Dental AG
Dental · 90d
Cleared Aug 24, 1998
AIRDENT RADIANCE CURING LIGHT
K982615
Air Techniques, Inc.
Dental · 28d
Cleared Jan 06, 1998
APOLLO 9500
K974369
Ion Laser Technology
Dental · 47d
Cleared Aug 29, 1997
3M AURORA SYSTEM
K972355
3M Company
Dental · 65d
Cleared Jul 10, 1997
ACTA OEM MODULE
K972006
Interactive Consulting, Inc.
Dental · 41d
Cleared Jun 04, 1997
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
K970506
Benlioglu Dental Ithalat, Inc.
Dental · 114d
Cleared Mar 18, 1997
ILT ARGON HP
K964524
Ion Laser Technology
Dental · 126d
Cleared Oct 24, 1996
JETLITE
K963110
J. Morita USA, Inc.
Dental · 73d
Cleared Jul 31, 1996
ACTA
K961735
Satelec
Dental · 89d
Cleared Apr 15, 1996
Q-LUX LIGHT CURE UNIT
K960351
Rolence Enterprise Co. , Ltd.
Dental · 81d
Cleared Apr 15, 1996
CU-200 LIGHT CURE UNIT
K960364
Rolence Enterprise Co. , Ltd.
Dental · 81d
Cleared Feb 15, 1996
ACL-5500 PRECISION CURING UNIT (PCU)
K953898
Ion Laser Technology
Dental · 181d
Cleared Jan 04, 1996
OPTILUX 400
K955763
Demetron Research Corp.
Dental · 15d
Cleared Jan 02, 1996
LITEX 680
K955759
Dentamerica
Dental · 15d
Cleared May 24, 1995
COLTOLUX 3, COLTOLUX 4
K945698
Coltene/Whaledent, Inc.
Dental · 188d