EBZ · Class II · 21 CFR 872.6070

FDA Product Code EBZ: Activator, Ultraviolet, For Polymerization

Leading manufacturers include Monitex Industrial Co., Ltd., Rolence Enterprise Co. , Ltd. and Ultradent Products, Inc..

214
Total
214
Cleared
95d
Avg days
1977
Since
214 devices
145–168 of 214
Cleared Oct 10, 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
K001719
Rolence Enterprise Co. , Ltd.
Dental · 127d
Cleared May 15, 2000
JETLITE 4000
K000078
J. Morita USA, Inc.
Dental · 125d
Cleared Apr 12, 2000
VIP- VARIABLE INTENSITY POLYMERIZER
K000426
Bisco, Inc.
Dental · 63d
Cleared Mar 27, 2000
NOVA CORDLESS CURING LIGHT
K000393
Nova/Da Vinci Systems, Inc.
Dental · 49d
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