FDA 510(k) Applications for Medical Device Product Code "EBZ"
(Activator, Ultraviolet, For Polymerization)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K032099 | (EMS SA) ELECTRO MEDICAL SYSTEMS | SWISS MASTER LIGHT | 10/27/2003 |
| K972355 | 3M COMPANY | 3M AURORA SYSTEM | 08/29/1997 |
| K061395 | ADDENT, INC. | CALSET COMPOSITE HEATER | 06/23/2006 |
| K982615 | AIR TECHNIQUES, INC. | AIRDENT RADIANCE CURING LIGHT | 08/24/1998 |
| K070373 | APOZA ENTERPRISE CO. LTD. | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | 03/02/2007 |
| K033201 | APOZA ENTERPRISE CO. LTD. | LA500 BLUE LIGHT | 12/02/2003 |
| K040618 | APOZA ENTERPRISE CO. LTD. | LED TURBO | 03/25/2004 |
| K041303 | APOZA ENTERPRISE CO. LTD. | LED TURBO-PEN | 06/18/2004 |
| K970506 | BENLIOGLU DENTAL ITHALAT INC. | HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT | 06/04/1997 |
| K052122 | BISCO, INC. | BISCO LED | 03/29/2006 |
| K000426 | BISCO, INC. | VIP- VARIABLE INTENSITY POLYMERIZER | 04/12/2000 |
| K023721 | BONART CO. LTD. | BONART ART-L2 LIGHT CURING UNIT | 01/10/2003 |
| K062289 | BONART CO. LTD. | BONART ART-L3 LED CURING LIGHT | 01/03/2007 |
| K082971 | BONART CO. LTD. | BONART ART-L5 LED CORDLESS CURING LIGHT | 11/13/2008 |
| K150585 | CAO GROUP, INC. | Ascent 3D | 12/31/2015 |
| K020057 | CAO GROUP, INC. | PALMLIGHT | 08/27/2002 |
| K061341 | CAO GROUP, INC. | PALMLIGHT 10, MODEL 001-00030 | 06/12/2006 |
| K010133 | CENTRIX, INC. | VERSALUX | 04/05/2001 |
| K221152 | Changzhou Sifary Medical Technology Co., Ltd. | CuringPen Dental Curing Light | 11/23/2022 |
| K040551 | COLTENE/WHALEDENT INC. | COLTOLUX LED CURING LIGHT | 03/15/2004 |
| K955763 | DEMETRON RESEARCH CORP. | OPTILUX 400 | 01/04/1996 |
| K081287 | DEN-MAT HOLDINGS, LLC | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | 11/21/2008 |
| K042196 | DENFOTEX LIGHT SYSTEMS LTD | SAVEDENT BLUE | 11/01/2004 |
| K063659 | DENT CORP. RESEARCH & DEVELOPMENT | EASY CURING PEN-STYLE LED CURING LIGHT | 04/30/2007 |
| K072807 | DENT'N CO | I LIGHT | 11/21/2007 |
| K223142 | Dent4You AG | Coltolux Comfort LED Curing Light | 12/22/2022 |
| K033697 | DENTAL PRODUCTS OF USA, INC. | POWER LED | 02/27/2004 |
| K002925 | DENTAL SYSTEMS.COM, INC. | COOLBLU CURING LIGHT | 12/20/2000 |
| K020171 | DENTAL SYSTEMS.COM, INC. | COOLBLU2 DENTAL RESIN CURING DEVICE | 01/29/2002 |
| K170529 | DENTALL Co., Ltd. | Delight, Delight ortho, B&Lite S | 08/08/2017 |
| K061658 | DENTALL CORP. | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L | 09/18/2006 |
| K140432 | DENTALL CORPORATION | HI-LIGHT, HI-LIGHT PLUS | 08/03/2015 |
| K955759 | DENTAMERICA | LITEX 680 | 01/02/1996 |
| K030641 | DENTAURUM | CONTEC LIGHT | 06/10/2003 |
| K052593 | DENTLIGHT INC. | FUSION CURING LIGHT | 09/28/2005 |
| K180065 | DentLight Inc. | FUSION Plus Curing Light | 04/19/2019 |
| K221194 | Dentmate Technology Co. Ltd. | LEDEX | 09/16/2022 |
| K131042 | DENTMATE TECHNOLOGY CO., LTD. | LEDEX | 10/03/2013 |
| K163605 | DENTMATE TECHNOLOGY CO., LTD. | LEDEX WL070+ | 01/19/2017 |
| K082408 | DENTMATE TECHNOLOGY CO., LTD. | LEDEX, MODEL: WL-070 | 12/03/2008 |
| K031615 | DENTSPLY INTERNATIONAL | SLED CURING LIGHT SYSTEM | 07/21/2003 |
| K041372 | DENTSPLY INTERNATIONAL | SMARTLITE PS PEN-STYLE LED CURING LIGHT | 06/24/2004 |
| K191865 | Dentsply Sirona | SmartLite Pro Modular LED Curing Light | 11/20/2019 |
| K043530 | DESIGNS FOR VISION, INC. | DVI CURING LIGHT | 01/25/2005 |
| K130163 | DIADENT GROUP INTERNATIONAL | D-LUX | 08/16/2013 |
| K200809 | Diadent Group International | D-LUX+ | 08/07/2020 |
| K023748 | DISCUS DENTAL, INC. | FLASH-LITE II LED DENTAL CURING LIGHT | 01/17/2003 |
| K022184 | DISCUS DENTAL, INC. | FLASH-LITE LED DENTAL CURING LIGHT | 08/20/2002 |
| K073518 | DISCUS DENTAL, INC. | FLASHLITE REBEL* | 12/20/2007 |
| K051571 | DMETEC CO., LTD. | SKYLIGHT LED CURING LIGHT | 07/19/2005 |
| K173876 | DXM Co., Ltd | Cybird LED Curing Light | 01/24/2018 |
| K191221 | DXM Co., Ltd | Cybird LED Curing Light | 01/10/2020 |
| K042703 | DXM CO., LTD. | CYBIRD LED CURING LIGHT | 10/12/2004 |
| K121093 | DXM CO., LTD. | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | 11/27/2012 |
| K071722 | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | DEEP BLUE | 08/10/2007 |
| K033795 | EELE LABORATORIES, LLC | PLASMACURE BXE | 12/19/2003 |
| K140281 | EPIC MEDICAL CONCEPTS & INNOVATIONS | FLEXI-LUME LED SYSTEM | 07/24/2014 |
| K011154 | ESPE DENTAL AG | ELIPAR FREELIGHT | 05/16/2001 |
| K984247 | ESPE DENTAL AG | ELIPAR TRILIGHT | 02/25/1999 |
| K192009 | EZGO Group Inc. | LED Curing Light | 01/09/2020 |
| K040956 | FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. | HILUX LEDMAX 3 | 06/14/2004 |
| K192233 | Foshan CICADA Dental Instrument Co., Ltd. | LED Curing Light | 02/13/2020 |
| K220826 | Foshan COXO Medical Instrument Co., Ltd. | LED Curing Light | 12/08/2022 |
| K243921 | Foshan COXO Medical Instrument Co., Ltd. | LED Curing Lights (DB686 HALO) | 04/11/2025 |
| K200775 | Garrison Dental Solutions, LLC | LOOP LED Curing Light System | 08/14/2020 |
| K241238 | Garrison Dental Solutions, LLC | LOOPÖ LED Curing Light System (CLK01) | 08/01/2024 |
| K050059 | GC AMERICA, INC. | G-LIGHT | 02/03/2005 |
| K012134 | GC AMERICA, INC. | GC E-LIGHT | 08/07/2001 |
| K242386 | GENOSS Co., Ltd. | Bluemoon | 05/05/2025 |
| K093751 | GOOD DOCTORS CO., LTD. | CL-DC20, CL-DC21 | 02/24/2010 |
| K223507 | Good Doctors Co., Ltd. | CL-DP40 (DrÆs Light PRIME), CL-DP40 (DrÆs Light CHOICE) | 08/04/2023 |
| K071908 | GOOD DOCTORS CO., LTD. | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | 08/23/2007 |
| K173157 | Good Doctors Co.,Ltd. | Dr's Light2 | 05/29/2018 |
| K994048 | GREGORY S. JACOB, D.D.S. | PORTABLE LIGHT CURING UNIT | 01/13/2000 |
| K223414 | Guilin Refine Medical Instrument Co., Ltd. | Curing Light, Model: MaxCure 9 | 11/15/2023 |
| K080025 | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD | LED.L, LED.M, LED.G, LED.B | 03/19/2008 |
| K233518 | Handpiece Headquarters | BASE290 LED Curing Light | 11/02/2023 |
| K042199 | HERAEUS KULZER GMBH | TRANSLUX POWER BLUE | 09/08/2004 |
| K012341 | HERAEUS KULZER, INC. | TRANSLUX ENERGY | 08/30/2001 |
| K992357 | ICS OF NORTH AMERICA, INC. | EASY-CURE (CURING AND WHITENING LIGHT) | 08/30/1999 |
| K170101 | Inter-Med / Vista Dental Products | Valiant Curing Light | 06/08/2017 |
| K972006 | INTERACTIVE CONSULTING, INC. | ACTA OEM MODULE | 07/10/1997 |
| K062735 | INVISIBLE TECHNOLOGY CO., LTD. | TUTU 7, MODEL IV-T22 | 10/27/2006 |
| K953898 | ION LASER TECHNOLOGY | ACL-5500 PRECISION CURING UNIT (PCU) | 02/15/1996 |
| K974369 | ION LASER TECHNOLOGY | APOLLO 9500 | 01/06/1998 |
| K964524 | ION LASER TECHNOLOGY | ILT ARGON HP | 03/18/1997 |
| K190272 | Ivoclar Vivadent, AG | Bluephase PowerCure | 07/03/2019 |
| K163613 | IVOCLAR VIVADENT, AG | Bluephase Style 20i | 04/04/2017 |
| K013275 | IVOCLAR VIVADENT, INC. | ASTRALIS 10, MODELS # 559588, 561859 | 10/19/2001 |
| K013277 | IVOCLAR VIVADENT, INC. | ASTRALIS 7, MODEL 557545 | 10/22/2001 |
| K033520 | IVOCLAR VIVADENT, INC. | BLUEPHASE | 12/05/2003 |
| K051782 | IVOCLAR VIVADENT, INC. | BLUEPHASE 16I | 09/20/2005 |
| K091020 | IVOCLAR VIVADENT, INC. | BLUEPHASE 20I | 06/12/2009 |
| K110756 | IVOCLAR VIVADENT, INC. | BLUEPHASE STYLE | 08/29/2011 |
| K963110 | J. MORITA USA, INC. | JETLITE | 10/24/1996 |
| K000078 | J. MORITA USA, INC. | JETLITE 4000 | 05/15/2000 |
| K051780 | J. MORITA USA, INC. | JETLITE 5000 | 07/28/2005 |
| K063529 | J. MORITA USA, INC. | PENCURE, MODEL VL-7 | 01/05/2007 |
| K040614 | J.L. BLOSSER, INC. | BLUEWAND LED DENTAL CURING WAND SYSTEM | 04/07/2004 |
| K003683 | JENERIC/PENTRON, INC. | AVANTE CURELIGHT | 01/11/2001 |
| K013500 | KAVO AMERICA | KAVO POLYLUX II | 01/14/2002 |
| K042888 | KERR CORP. | DEMETRON IDS CURING LIGHT | 11/10/2004 |
| K014179 | KERR CORP. | DEMETRON LC | 02/04/2002 |
| K071251 | KERR CORPORATION | DEMI | 07/26/2007 |
| K163064 | KERR CORPORATION | Demi Ultra | 07/18/2017 |
| K123468 | KERR CORPORATION | DEMI ULTRA | 03/20/2013 |
| K102621 | KERR CORPORATION | SOLSTICE | 01/28/2011 |
| K051545 | KERR CORPORATION (DANBURY) | L.E. DEMETRON II | 07/18/2005 |
| K020091 | KERR CORPORATION (DANBURY) | OPTILUX 501 | 03/21/2002 |
| K012946 | KINETIC INSTRUMENTS, INC. | SUNLITELED MODEL #2810 | 10/02/2001 |
| K022862 | KINETIC INSTRUMENTS, INC. | TRANSCURE, MODEL 2910 | 10/18/2002 |
| K181597 | KMIHH Ltd | Le'Pen | 04/01/2019 |
| K994028 | LOKKI | FLIPO XENON CURING LIGHT | 01/12/2000 |
| K024374 | LOKKI LASERS MEDICAUX | RMO PLASMA CURING LIGHT | 03/10/2003 |
| K002566 | LUMALITE, INC. | LUMALITE CURE LIGHT, MODEL 2100 | 10/19/2000 |
| K992236 | LYSTA A/S | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA | 08/27/1999 |
| K991138 | LYSTA A/S | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA | 04/23/1999 |
| K092951 | MECTRON S.P.A. | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS | 12/07/2009 |
| K993223 | MEDIPHOTONIX, LC | RAPICURE 200 (CURING AND WHITENING LIGHT) | 11/01/1999 |
| K060646 | MONITEX INDUSTRIAL CO., LTD. | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | 04/21/2006 |
| K051203 | MONITEX INDUSTRIAL CO., LTD. | BLUELEX | 05/25/2005 |
| K133040 | MONITEX INDUSTRIAL CO., LTD. | LED CURING LIGHT | 10/07/2014 |
| K152192 | MONITEX INDUSTRIAL CO., LTD. | LED Curing Light | 04/07/2017 |
| K080035 | MONITEX INDUSTRIAL CO., LTD. | LED CURING LIGHT | 03/03/2008 |
| K150205 | MONITEX INDUSTRIAL CO., LTD. | LED Curing Light | 08/24/2015 |
| K161855 | MONITEX INDUSTRIAL CO., LTD. | LED Curing Light | 11/27/2017 |
| K153078 | MONITEX INDUSTRIAL CO., LTD. | LED Curing Light GT-2000 | 06/28/2016 |
| K091887 | MONITEX INDUSTRIAL CO., LTD. | LED CURING LIGHT, MODEL GT-1500 | 09/18/2009 |
| K152936 | NATIONAL DENTAL INC. | Sirius Max Dental Diode Curing Light | 11/13/2015 |
| K043302 | NOVA RANGER, INC. | NOVA-PULSE | 01/03/2005 |
| K000393 | NOVA/DA VINCI SYSTEMS, INC. | NOVA CORDLESS CURING LIGHT | 03/27/2000 |
| K063003 | PARKELL, INC. | AURORA | 11/28/2006 |
| K061695 | PENG LIM ENTERPRISE CO., LTD. | LED PROLUX 770 | 09/14/2006 |
| K052349 | PENTRON CLINICAL TECHNOLOGIES | AVANTE LED CURING UNIT, MODEL N44 | 10/21/2005 |
| K250009 | Premium Plus (Dongguan) Limited | LED Curing Light (C01-X, C02-X) | 04/10/2025 |
| K153514 | PREMIUM PLUS INTERNATIONAL LIMITED | Premium Plus C01/C02 LED Curing Light | 08/22/2016 |
| K172426 | Promident LLC | Clear Blue Digi LED Curing Light | 08/16/2017 |
| K023652 | REMEDENT NV | REMECURE MODEL CL 15E | 01/09/2003 |
| K020884 | ROLENCE ENT. INC. | EXCELLITE LIGHT CURE UNIT | 06/12/2002 |
| K020877 | ROLENCE ENT. INC. | EXCELLITE TURBO LIGHT CURE UNIT | 06/12/2002 |
| K023545 | ROLENCE ENT. INC. | ULTRA-LITE 200E LIGHT CURE UNIT | 12/30/2002 |
| K020874 | ROLENCE ENT. INC. | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | 06/12/2002 |
| K960364 | ROLENCE ENTERPRISE CO. LTD. | CU-200 LIGHT CURE UNIT | 04/15/1996 |
| K991863 | ROLENCE ENTERPRISE CO. LTD. | CUTE-LITE I LIGHT CURE UNIT | 07/19/1999 |
| K991865 | ROLENCE ENTERPRISE CO. LTD. | Q-LITE 75 LIGHT CURE UNIT | 07/20/1999 |
| K960351 | ROLENCE ENTERPRISE CO. LTD. | Q-LUX LIGHT CURE UNIT | 04/15/1996 |
| K001719 | ROLENCE ENTERPRISE CO. LTD. | Q-LUX PLASMA 100 LIGHT CURE UNIT | 10/10/2000 |
| K030811 | SAMM, INC. | COOL CURE | 06/10/2003 |
| K961735 | SATELEC | ACTA | 07/31/1996 |
| K040808 | SATELEC | MINI L.E.D. OEM MODULE | 04/28/2004 |
| K032465 | SATELEC | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | 10/21/2003 |
| K072181 | SATELEC | MINI LED AUTOFOCUS | 09/19/2007 |
| K131906 | SATELEC-ACTEON GROUP | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | 04/11/2014 |
| K002991 | SOFT-CORE TEXAS, INC. | ZAP DUAL CURING LIGHT | 11/28/2000 |
| K030568 | SOUTHERN DENTAL INDUSTRIES, INC. | RADII | 04/24/2003 |
| K992728 | SPRING HEALTH PRODUCTS, INC. | SPRING POWERLITE 2000 | 09/29/1999 |
| K022265 | SVENSKA DENTAL INSTRUMENTS AB | LIGHT TIP | 10/02/2002 |
| K063116 | SYBRON DENTAL SPECIALTIES | DEMETRON A.2 | 12/05/2006 |
| K021797 | SYBRON DENTAL SPECIALTIES, INC. | L.E.DEMETRON | 06/27/2002 |
| K020267 | SYBRON DENTAL SPECIALTIES, INC. | OPTILUX CURING LIGHTS | 03/29/2002 |
| K021374 | TOEI ELECTRIC CO., LTD. | TOESCO AQUA BLUE LED LIGHT CURING DEVICE | 05/30/2002 |
| K210550 | Ultradent Products, Inc | VALO Grand Corded and Accessory Lenses | 03/01/2021 |
| K003383 | ULTRADENT PRODUCTS, INC. | PALMLIGHT | 02/06/2001 |
| K110582 | ULTRADENT PRODUCTS, INC. | VALO CORDLESS | 04/28/2011 |
| K160551 | ULTRADENT PRODUCTS, INC. | VALO Grand | 07/13/2016 |
| K190627 | Ultradent Products, Inc. | VALO Grand Corded | 04/29/2019 |
| K220471 | Ultradent Products, Inc. | VALO X, VALO X Accessory Lenses | 02/22/2022 |
| K083647 | ULTRADENT PRODUCTS, INC. | VALO, MODEL 5919 | 01/23/2009 |
| K153018 | VOCO GMBH | CELALUX 3 | 06/23/2016 |
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