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
49–72 of 214
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 Aug 29, 1997
3M AURORA SYSTEM
K972355
3M Company
Dental · 65d
Cleared Oct 24, 1996
JETLITE
K963110
J. Morita USA, Inc.
Dental · 73d
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 Sep 06, 1988
PHOTO-CURING LIGHT
K882145
Dentsply Intl.
Dental · 106d
Cleared Aug 31, 1983
PRISMA III
K832320
Dentsply Intl.
Dental · 47d
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 Apr 05, 1977
NUVA-LITE II PHOTO-CURE UNIT
K770599
Dentsply Intl.
Dental · 7d