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
121–144 of 214
Cleared Aug 27, 2002
PALMLIGHT
K020057
CAO Group, Inc.
Dental · 231d
Cleared Aug 20, 2002
FLASH-LITE LED DENTAL CURING LIGHT
K022184
Discus Dental, Inc.
Dental · 48d
Cleared Jun 27, 2002
L.E.DEMETRON
K021797
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Jun 12, 2002
ULTRA-LITE 5 TURBO LIGHT CURE UNIT
K020874
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE TURBO LIGHT CURE UNIT
K020877
Rolence Ent., Inc.
Dental · 86d
Cleared Jun 12, 2002
EXCELLITE LIGHT CURE UNIT
K020884
Rolence Ent., Inc.
Dental · 86d
Cleared May 30, 2002
TOESCO AQUA BLUE LED LIGHT CURING DEVICE
K021374
Toei Electric Co., Ltd.
Dental · 29d
Cleared Mar 29, 2002
OPTILUX CURING LIGHTS
K020267
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Mar 21, 2002
OPTILUX 501
K020091
Kerr Corporation (Danbury)
Dental · 70d
Cleared Feb 04, 2002
DEMETRON LC
K014179
Kerr Corp.
Dental · 46d
Cleared Jan 29, 2002
COOLBLU2 DENTAL RESIN CURING DEVICE
K020171
Dental Systems.Com, Inc.
Dental · 12d
Cleared Jan 14, 2002
KAVO POLYLUX II
K013500
Kavo America
Dental · 84d
Cleared Oct 22, 2001
ASTRALIS 7, MODEL 557545
K013277
Ivoclar Vivadent, Inc.
Dental · 20d
Cleared Oct 19, 2001
ASTRALIS 10, MODELS # 559588, 561859
K013275
Ivoclar Vivadent, Inc.
Dental · 18d
Cleared Oct 02, 2001
SUNLITELED MODEL #2810
K012946
Kinetic Instruments, Inc.
Dental · 28d
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341
Heraeus Kulzer, Inc.
Dental · 37d
Cleared Aug 07, 2001
GC E-LIGHT
K012134
GC America, Inc.
Dental · 29d
Cleared May 16, 2001
ELIPAR FREELIGHT
K011154
Espe Dental AG
Dental · 30d
Cleared Apr 05, 2001
VERSALUX
K010133
Centrix, Inc.
Dental · 78d
Cleared Feb 06, 2001
PALMLIGHT
K003383
Ultradent Products, Inc.
Dental · 98d
Cleared Jan 11, 2001
AVANTE CURELIGHT
K003683
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Dec 20, 2000
COOLBLU CURING LIGHT
K002925
Dental Systems.Com, Inc.
Dental · 92d
Cleared Nov 28, 2000
ZAP DUAL CURING LIGHT
K002991
Soft-Core Texas, Inc.
Dental · 64d
Cleared Oct 19, 2000
LUMALITE CURE LIGHT, MODEL 2100
K002566
Lumalite, Inc.
Dental · 63d