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
25–48 of 214
Cleared Apr 01, 2019
Le'Pen
K181597
Kmihh, Ltd.
Dental · 287d
Cleared May 29, 2018
Dr's Light2
K173157
Good Doctors Co., Ltd.
Dental · 242d
Cleared Jan 24, 2018
Cybird LED Curing Light
K173876
Dxm Co., Ltd.
Dental · 34d
Cleared Nov 27, 2017
LED Curing Light
K161855
Monitex Industrial Co., Ltd.
Dental · 509d
Cleared Aug 16, 2017
Clear Blue Digi LED Curing Light
K172426
Promident, LLC
Dental · 6d
Cleared Aug 08, 2017
Delight, Delight ortho, B&Lite S
K170529
Dentall Co., Ltd.
Dental · 167d
Cleared Jul 18, 2017
Demi Ultra
K163064
Kerr Corporation
Dental · 258d
Cleared Jun 08, 2017
Valiant Curing Light
K170101
Inter-Med/Vista Dental Products
Dental · 148d
Cleared Apr 07, 2017
LED Curing Light
K152192
Monitex Industrial Co., Ltd.
Dental · 611d
Cleared Apr 04, 2017
Bluephase Style 20i
K163613
Ivoclar Vivadent, AG
Dental · 103d
Cleared Jan 19, 2017
LEDEX WL070+
K163605
Dentmate Technology Co. , Ltd.
Dental · 29d
Cleared Aug 22, 2016
Premium Plus C01/C02 LED Curing Light
K153514
Premium Plus International Limited
Dental · 259d
Cleared Jul 13, 2016
VALO Grand
K160551
Ultradent Products, Inc.
Dental · 135d
Cleared Jun 28, 2016
LED Curing Light GT-2000
K153078
Monitex Industrial Co., Ltd.
Dental · 249d
Cleared Jun 23, 2016
CELALUX 3
K153018
Voco GmbH
Dental · 252d
Cleared Dec 31, 2015
Ascent 3D
K150585
CAO Group, Inc.
Dental · 297d
Cleared Nov 13, 2015
Sirius Max Dental Diode Curing Light
K152936
National Dental, Inc.
Dental · 39d
Cleared Aug 24, 2015
LED Curing Light
K150205
Monitex Industrial Co., Ltd.
Dental · 207d
Cleared Aug 03, 2015
HI-LIGHT, HI-LIGHT PLUS
K140432
Dentall Corporation
Dental · 529d
Cleared Oct 07, 2014
LED CURING LIGHT
K133040
Monitex Industrial Co., Ltd.
Dental · 377d
Cleared Jul 24, 2014
FLEXI-LUME LED SYSTEM
K140281
Epic Medical Concepts & Innovations
Dental · 170d
Cleared Apr 11, 2014
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
K131906
Satelec - Acteon Group
Dental · 289d
Cleared Oct 03, 2013
LEDEX
K131042
Dentmate Technology Co. , Ltd.
Dental · 171d
Cleared Aug 16, 2013
D-LUX
K130163
DiaDent Group International
Dental · 205d