Activator, Ultraviolet, For Polymerization

Product Code: EBZ

Dental Ultraviolet Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 872.6070


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as EBZ

1130Activator, Ultraviolet, For PolymerizationUltraviolet Activator For Polymerization.

Total Product Life Cycle (TPLC) Devices

1130Activator, Ultraviolet, For PolymerizationUltraviolet Activator For Polymerization.

FDA Consensus Standards

Activator, Ultraviolet, For Polymerization [34868]21 CFR §872.6070 🔎
Activator, Ultraviolet, For Polymerization [32396]21 CFR §872.6070 🔎
Activator, Ultraviolet, For Polymerization [32397]21 CFR §872.6070 🔎
Activator, Ultraviolet, For Polymerization [38731]21 CFR §872.6070 🔎
Activator, Ultraviolet, For Polymerization [33852]21 CFR §872.6070 🔎
Activator, Ultraviolet, For Polymerization [38730]21 CFR §872.6070 🔎

Pre-market Notifications for EBZ

K221194LEDEXDentmate Technology Co. Ltd.
K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd.
K220826LED Curing LightFoshan COXO Medical Instrument Co., Ltd.
K220471VALO X, VALO X Accessory LensesUltradent Products, Inc.
K210550VALO Grand Corded And Accessory LensesUltradent Products, Inc
K200809D-LUX+Diadent Group International
K200775LOOP LED Curing Light SystemGarrison Dental Solutions, LLC
K192233LED Curing LightFoshan CICADA Dental Instrument Co., Ltd.
K192009LED Curing LightEZGO Group Inc.
K191865SmartLite Pro Modular LED Curing LightDentsply Sirona
K191221Cybird LED Curing LightDXM Co., Ltd
K190627VALO Grand CordedUltradent Products, Inc.
K190272Bluephase PowerCureIvoclar Vivadent, AG
K181597Le'PenKMIHH Ltd
K180065FUSION Plus Curing LightDentLight Inc.

Global Unique Device Identification Database

00366975003614Activator, Ultraviolet, For Polymerization
00366975003607Activator, Ultraviolet, For Polymerization
00366975003591Activator, Ultraviolet, For Polymerization
00366975003577Activator, Ultraviolet, For Polymerization
00366975003560Activator, Ultraviolet, For Polymerization
10304040054366ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054304ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054274ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054267ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054250ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054243ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
10304040054236ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
00652221149312ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
00810000520183Activator, Ultraviolet, For Polymerization
00810000520176Activator, Ultraviolet, For Polymerization

Maude Adverse Events

TRANSLUXKULZER GMBH - HQ2020-01-15
TRANSLUX 2WAVEKULZER GMBH2020-01-08
TRANSLUX? WAVEKULZER,LLC2018-05-17
BLUEPHASE G2IVOCLAR VIVADENT, GMBH2018-01-19
VALO CORDLESS CURING LIGHTULTRADENT PRODUCTS INC.2018-01-15
VALO CORDLESS BATTERY CHARGING UNIT2017-12-21
TRANSLUX WAVEKULZER, GMBH2017-08-16
3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT3M DEUTSCHLAND GMBH2017-07-18
VALO GRANDULTRADENT PRODUCTS, INC.2017-03-06
TRANSLUX WAVEHERAEUS KULZER GMBH2017-03-06
1703L CROSS CUT FISSURE ORAL SURGERY BURSS WHITE2016-12-09
MAXIMA RU1200HENRY SCHEIN2016-02-08
TRANSLUX? WAVEHERAEUS KULZER GMBH2016-02-03
VALO CURING LIGHTULTRADENT PRODUCTS INC.2015-06-29
VALO CURING LIGHTULTRADENT PRODUCTS INC2015-06-29
GLUMA ETCH 35 FLUID 15ML FLHERAEUS KULZER GMBH2015-05-07
DEMI PLUSKERR CORPORATION2015-04-10
DEMI PLUSKERR CORPORATION2015-04-10
DEMI PLUSKERR CORPORATION2015-04-10
DEMI PLUSKERR CORPORATION2015-04-10
TRANSLUX WAVEHERAEUS KULZER GMBH2015-04-01
DEMIKERR CORPORATION2014-11-10
DEMIKERR CORPORATION2014-11-10
BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE)IVOCLAR VIVADENT, GMBH2014-09-24
BLUEPHASE LIGHT PROBE 10MM BLACK (STYLEIVOCLAR VIVADENT, AG2014-09-16
L.E. DEMETRON IIKERR CORPORATION2014-09-04
OPTILUX 501KERR CORPORATION2014-08-29
DEMI PLUSKERR CORPORATION2014-08-06
DEMI PLUSKERR CORPORATION2014-08-06
DEMI PLUSKERR CORPORATION2014-08-06
DEMI PLUSKERR CORPORATION2014-08-06
DEMI PLUSKERR CORPORATION2014-08-06
DEMIKERR CORPORATION2014-08-06
DEMIKERR CORPORATION2014-05-23
FLASH LITE MAGNADISCUS DENTAL, LLC2014-05-23
DEMIKERR CORPORATION2014-05-23
DEMIKERR CORPORATION2014-05-23
BATTERY CHARGER, SINGLE BAYINTEGRA BURLINGTON, MA, INC.2014-05-09
DEMI PLUSKERR CORPORATION2014-04-29
DEMI PLUSKERR CORPORATION2014-04-29
DEMI PLUSKERR CORPORATION2014-04-29
DEMI PLUSKERR CORPORATION2014-04-29
DEIMULTRAKERR CORPORATION2014-04-07
DEMIULTRAKERR CORPORATION2014-04-07
DEMIULTRAKERR CORPORATION2014-04-07
HEAT GUN2014-01-13
TRANSLUX? POWER BLUEHERAEUS KULZER GMBH2014-01-10
TRANSLUX? POWER BLUEHERAEUS KULZER GMBH2014-01-10
TRANSLUX? POWER BLUEHERAEUS KULZER GMBH2014-01-10
TRANSLUX? POWER BLUEHERAEUS KULZER GMBH2014-01-10
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