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 Dentsply Intl..

214
Total
214
Cleared
95d
Avg days
1977
Since
214 devices
73–96 of 214
Cleared Jun 24, 2004
SMARTLITE PS PEN-STYLE LED CURING LIGHT
K041372
Dentsply International
Dental · 31d
Cleared Jun 18, 2004
LED TURBO-PEN
K041303
Apoza Enterprise Co., Ltd.
Dental · 32d
Cleared Apr 28, 2004
MINI L.E.D. OEM MODULE
K040808
Satelec
Dental · 30d
Cleared Mar 15, 2004
COLTOLUX LED CURING LIGHT
K040551
Coltene/Whaledent, Inc.
Dental · 13d
Cleared Dec 05, 2003
BLUEPHASE
K033520
Ivoclar Vivadent, Inc.
Dental · 28d
Cleared Oct 21, 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465
Satelec
Dental · 71d
Cleared Jul 21, 2003
SLED CURING LIGHT SYSTEM
K031615
Dentsply International
Dental · 59d
Cleared Apr 24, 2003
RADII
K030568
Southern Dental Industries, Inc.
Dental · 59d
Cleared Aug 27, 2002
PALMLIGHT
K020057
CAO Group, Inc.
Dental · 231d
Cleared Jun 27, 2002
L.E.DEMETRON
K021797
Sybron Dental Specialties, Inc.
Dental · 27d
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 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 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 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 Jan 13, 2000
PORTABLE LIGHT CURING UNIT
K994048
Gregory S. Jacob, D.D.S.
Dental · 48d