Activator, Ultraviolet, For Polymerization

FDA product code EBZ · 207 cleared devices

Class 2 Dental

Regulation: 21 CFR 872.6070
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-28 – 2026-06-18

EBZ 2003-10-27

SWISS MASTER LIGHT

Applicant (Ems Sa) Electro Medical Systems

K number K032099

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EBZ 2003-10-21

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

Applicant Satelec

K number K032465

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EBZ 2003-07-21

SLED CURING LIGHT SYSTEM

Applicant Dentsply International

K number K031615

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EBZ 2003-06-10

COOL CURE

Applicant Samm, Inc.

K number K030811

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EBZ 2003-06-10

CONTEC LIGHT

Applicant Dentaurum

K number K030641

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EBZ 2003-04-24

RADII

Applicant Southern Dental Industries, Inc.

K number K030568

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EBZ 2003-03-10

RMO PLASMA CURING LIGHT

Applicant Lokki Lasers Medicaux

K number K024374

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EBZ 2003-01-17

FLASH-LITE II LED DENTAL CURING LIGHT

Applicant Discus Dental, Inc.

K number K023748

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EBZ 2003-01-10

BONART ART-L2 LIGHT CURING UNIT

Applicant Bonart Co., Ltd.

K number K023721

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EBZ 2003-01-09

REMECURE MODEL CL 15E

Applicant Remedent NV

K number K023652

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EBZ 2002-12-30

ULTRA-LITE 200E LIGHT CURE UNIT

Applicant Rolence Ent., Inc.

K number K023545

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EBZ 2002-10-18

TRANSCURE, MODEL 2910

Applicant Kinetic Instruments, Inc.

K number K022862

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EBZ 2002-10-02

LIGHT TIP

Applicant Svenska Dental Instruments AB

K number K022265

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EBZ 2002-08-27

PALMLIGHT

Applicant CAO Group, Inc.

K number K020057

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EBZ 2002-08-20

FLASH-LITE LED DENTAL CURING LIGHT

Applicant Discus Dental, Inc.

K number K022184

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EBZ 2002-06-27

L.E.DEMETRON

Applicant Sybron Dental Specialties, Inc.

K number K021797

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EBZ 2002-06-12

EXCELLITE LIGHT CURE UNIT

Applicant Rolence Ent., Inc.

K number K020884

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EBZ 2002-06-12

EXCELLITE TURBO LIGHT CURE UNIT

Applicant Rolence Ent., Inc.

K number K020877

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EBZ 2002-06-12

ULTRA-LITE 5 TURBO LIGHT CURE UNIT

Applicant Rolence Ent., Inc.

K number K020874

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EBZ 2002-05-30

TOESCO AQUA BLUE LED LIGHT CURING DEVICE

Applicant Toei Electric Co., Ltd.

K number K021374

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EBZ 2002-03-29

OPTILUX CURING LIGHTS

Applicant Sybron Dental Specialties, Inc.

K number K020267

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EBZ 2002-03-21

OPTILUX 501

Applicant Kerr Corporation (Danbury)

K number K020091

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EBZ 2002-02-04

DEMETRON LC

Applicant Kerr Corp.

K number K014179

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EBZ 2002-01-29

COOLBLU2 DENTAL RESIN CURING DEVICE

Applicant Dental Systems.Com, Inc.

K number K020171

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EBZ 2002-01-14

KAVO POLYLUX II

Applicant Kavo America

K number K013500

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EBZ 2001-10-22

ASTRALIS 7, MODEL 557545

Applicant Ivoclar Vivadent, Inc.

K number K013277

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EBZ 2001-10-19

ASTRALIS 10, MODELS # 559588, 561859

Applicant Ivoclar Vivadent, Inc.

K number K013275

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EBZ 2001-10-02

SUNLITELED MODEL #2810

Applicant Kinetic Instruments, Inc.

K number K012946

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EBZ 2001-08-30

TRANSLUX ENERGY

Applicant Heraeus Kulzer, Inc.

K number K012341

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EBZ 2001-08-07

GC E-LIGHT

Applicant GC America, Inc.

K number K012134

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EBZ 2001-05-16

ELIPAR FREELIGHT

Applicant Espe Dental AG

K number K011154

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EBZ 2001-04-05

VERSALUX

Applicant Centrix, Inc.

K number K010133

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EBZ 2001-02-06

PALMLIGHT

Applicant Ultradent Products, Inc.

K number K003383

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EBZ 2001-01-11

AVANTE CURELIGHT

Applicant Jeneric/Pentron, Inc.

K number K003683

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EBZ 2000-12-20

COOLBLU CURING LIGHT

Applicant Dental Systems.Com, Inc.

K number K002925

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EBZ 2000-11-28

ZAP DUAL CURING LIGHT

Applicant Soft-Core Texas, Inc.

K number K002991

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EBZ 2000-10-19

LUMALITE CURE LIGHT, MODEL 2100

Applicant Lumalite, Inc.

K number K002566

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EBZ 2000-10-10

Q-LUX PLASMA 100 LIGHT CURE UNIT

Applicant Rolence Enterprise Co. , Ltd.

K number K001719

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EBZ 2000-05-15

JETLITE 4000

Applicant J. Morita USA, Inc.

K number K000078

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EBZ 2000-04-12

VIP- VARIABLE INTENSITY POLYMERIZER

Applicant Bisco, Inc.

K number K000426

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EBZ 2000-03-27

NOVA CORDLESS CURING LIGHT

Applicant Nova/Da Vinci Systems, Inc.

K number K000393

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EBZ 2000-01-13

PORTABLE LIGHT CURING UNIT

Applicant Gregory S. Jacob, D.D.S.

K number K994048

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EBZ 2000-01-12

FLIPO XENON CURING LIGHT

Applicant Lokki

K number K994028

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EBZ 1999-11-01

RAPICURE 200 (CURING AND WHITENING LIGHT)

Applicant Mediphotonix, LC

K number K993223

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EBZ 1999-09-29

SPRING POWERLITE 2000

Applicant Spring Health Products, Inc.

K number K992728

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EBZ 1999-08-30

EASY-CURE (CURING AND WHITENING LIGHT)

Applicant Ics of North America, Inc.

K number K992357

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EBZ 1999-08-27

LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA

Applicant Lysta A/S

K number K992236

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EBZ 1999-07-20

Q-LITE 75 LIGHT CURE UNIT

Applicant Rolence Enterprise Co. , Ltd.

K number K991865

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EBZ 1999-07-19

CUTE-LITE I LIGHT CURE UNIT

Applicant Rolence Enterprise Co. , Ltd.

K number K991863

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EBZ 1999-04-23

LYSTA LC CURING LIGHT, MODEL LC 2500C/BA

Applicant Lysta A/S

K number K991138

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EBZ 1999-02-25

ELIPAR TRILIGHT

Applicant Espe Dental AG

K number K984247

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EBZ 1998-08-24

AIRDENT RADIANCE CURING LIGHT

Applicant Air Techniques, Inc.

K number K982615

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EBZ 1998-01-06

APOLLO 9500

Applicant Ion Laser Technology

K number K974369

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EBZ 1997-08-29

3M AURORA SYSTEM

Applicant 3M Company

K number K972355

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EBZ 1997-07-10

ACTA OEM MODULE

Applicant Interactive Consulting, Inc.

K number K972006

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EBZ 1997-06-04

HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT

Applicant Benlioglu Dental Ithalat, Inc.

K number K970506

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EBZ 1997-03-18

ILT ARGON HP

Applicant Ion Laser Technology

K number K964524

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EBZ 1996-10-24

JETLITE

Applicant J. Morita USA, Inc.

K number K963110

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EBZ 1996-07-31

ACTA

Applicant Satelec

K number K961735

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EBZ 1996-04-15

CU-200 LIGHT CURE UNIT

Applicant Rolence Enterprise Co. , Ltd.

K number K960364

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EBZ 1996-04-15

Q-LUX LIGHT CURE UNIT

Applicant Rolence Enterprise Co. , Ltd.

K number K960351

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EBZ 1996-02-15

ACL-5500 PRECISION CURING UNIT (PCU)

Applicant Ion Laser Technology

K number K953898

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EBZ 1996-01-04

OPTILUX 400

Applicant Demetron Research Corp.

K number K955763

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EBZ 1996-01-02

LITEX 680

Applicant Dentamerica

K number K955759

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EBZ 1995-09-21

POLY-LITE MODEL 1000

Applicant Pro-Den Systems, Inc.

K number K954061

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EBZ 1995-06-22

CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676

Applicant Rolence Enterprise Co. , Ltd.

K number K952423

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EBZ 1995-05-31

SUNLITE 1275

Applicant Fen Dental Mfg., Inc.

K number K951465

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EBZ 1995-05-24

COLTOLUX LIGHT METER

Applicant Coltene/Whaledent, Inc.

K number K950106

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EBZ 1995-05-24

COLTOLUX 3, COLTOLUX 4

Applicant Coltene/Whaledent, Inc.

K number K945698

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EBZ 1995-05-05

SPECTRUM CURING LIGHT POLYMERIZATION UNIT

Applicant Dentsply Intl.

K number K951425

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EBZ 1994-06-02

CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676

Applicant Rolence Enterprise Co. , Ltd.

K number K942199

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EBZ 1994-05-27

CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676

Applicant Rolence Enterprise Co. , Ltd.

K number K942198

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EBZ 1994-01-06

3M CURING LIGHT XL1500

Applicant 3M Company

K number K934746

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EBZ 1993-04-23

ORTHOLUX XT

Applicant 3M Company

K number K930086

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EBZ 1992-11-25

3M CURING LIGHT XL 3000

Applicant 3M Company

K number K924812

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EBZ 1991-12-23

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE

Applicant Wilde-USA, Inc.

K number K912994

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EBZ 1991-12-16

HELIOLUX

Applicant Ivoclar North America, Inc.

K number K913980

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EBZ 1991-03-15

SPECTRAMAT

Applicant Ivoclar North America, Inc.

K number K910068

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EBZ 1991-03-11

LARES APOLLO CS/CP/C

Applicant Lares Research, Inc.

K number K905543

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EBZ 1990-07-13

HELIOLUX VISIBLE CURING LIGHT

Applicant Ivoclar North America, Inc.

K number K901908

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EBZ 1990-05-07

CU-75 VISIBLE LIGHT-CURING UNIT

Applicant Kab Gloves Unltd.

K number K900135

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EBZ 1990-04-02

WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT

Applicant Lustgarten Multi-Tech International, Inc.

K number K895085

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EBZ 1989-08-21

TULUX-FILTER

Applicant Espe GmbH (Us)

K number K892517

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EBZ 1989-06-14

KULZER TRANSLUX EC

Applicant Kulzer, Inc.

K number K892456

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EBZ 1989-03-17

CURING LIGHT COVER

Applicant Steri-Shield Products, Inc.

K number K884222

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EBZ 1988-09-06

PHOTO-CURING LIGHT

Applicant Dentsply Intl.

K number K882145

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EBZ 1988-04-07

ORTHOLUX VISIBLE LIGHT CURING UNIT

Applicant Unitek Corp.

K number K880392

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EBZ 1986-03-26

OP II VISIBLE LIGHT CURING SYSTEM

Applicant Almore Intl., Inc.

K number K854696

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EBZ 1985-07-09

CURING LIGHT

Applicant Technology, Inc.

K number K851915

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EBZ 1984-12-21

OPTI-LITE

Applicant Innovators, Inc.

K number K844351

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EBZ 1984-12-11

COE-LITE POLYMERIZATION UNIT

Applicant Coe Laboratories, Inc.

K number K844325

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EBZ 1984-12-04

TRANSLUX CL

Applicant Kulzer, Inc.

K number K843823

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EBZ 1983-08-31

PRISMA III

Applicant Dentsply Intl.

K number K832320

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EBZ 1982-10-04

CURING LIGHT

Applicant Venture Technology, Inc.

K number K822654

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EBZ 1982-09-14

OPTILUX & VISILUX DENTAL PHOTO LAMP

Applicant Demetron Research Corp.

K number K822642

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EBZ 1982-04-09

MIDWEST LIGHT WAND

Applicant American Midwest

K number K820693

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EBZ 1981-07-28

KULZER TRANSLUX VISIBLE LIGHT CURING

Applicant Kulzer, Inc.

K number K811668

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EBZ 1981-01-14

ELIPAR LIGHT SOURCE

Applicant Espe-Premier Sales Co.

K number K803209

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EBZ 1980-09-16

CAULK PRISMA-LITE

Applicant Dentsply Intl.

K number K801588

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EBZ 1978-06-30

INSTANT CURE-1

Applicant Ultra-Light Corp.

K number K780898

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