Miscellaneous devices · 21 CFR 872 Subpart G
Ultraviolet Activator for Polymerization
FDA device type “Activator, Ultraviolet, For Polymerization”.
- Companies listing it
- 8752 makers
- Brands and models
- 228
- 510(k) clearances
- 21414 in five years
- FDA name
- Activator, Ultraviolet, For Polymerization
510(k) clearances per year, 1976–2026
Companies that list EBZ
87 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| DiaDent Group International | South Korea | Maker | D-Lux+ | 24 | 2026 |
| GC America Inc. | United States | Maker | G-LIGHT · Silverlight · The Light · The Light 405 | 137 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | B-Cure · Dental Curing Light · i Led · iLed II · +11 | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | Demi Plus, Light Guides · Demi Pro · Demi Ultra | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | VALO · VALO Accessory (16' cord Power Supply) · VALO Black Light Lens, VALO Grand Black Light Lens · Valo Corded Accessory (light shield, lenses, blocking glassses, bracket holder, charging unit power supply etc. · +24 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | ibond Etch 35 Fluid · Starlight Pro · Translux 2 Wave · TRANSLUX POWER BLUE · +1 | 37 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | GCL-01W | 23 | 2025 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | LED Curing Light; DB686 NANO, DB686 SWIFT · LED Curing Lights; DB686 HALO | 6 | 2025 |
| Ivoclar Vivadent, AG | United States | Maker | Bluephase EasyCure · Bluephase G4 · Bluephase G4 100 · Bluephase PowerCure | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | PinkWave · PinkWave Paddle · PinkWave Tacking Tips · Valiant | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | Coltolux Comfort LED Curing Light | 5 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | — | 24 | 2024 |
| Mectron S.P.A. | Italy | Maker | Silverlight · Starlight Pro | 11 | 2025 |
| Sdi Limited | Australia | Maker | Patterson Brand · Radii · Radii Cal · Radii Plus · +1 | 8 | 2022 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | CuringPen Dental Curing Light · Dental Curing light (Model: Kulzer Translux Cure) | 4 | 2026 |
| Guilin Refine Medical Instrument Co., LTD. | China | Maker | Curing Light (Model: MaxCure9) | 3 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Satelec - Acteon Group | United States | Maker | Activator Ultraviolet for Polymerization · MINI L.E.D SUPERCHARGED O.E.M · Mini L.E.D. , Celalux 2 · MINI L.E.D. OEM · +11 | 18 | 2024 |
| Den-Mat Holdings, LLC | United States | Maker | FLASHlite 2 · FLASHlite Magna 4 · Sapphire Plus Plasma Arc Curing Light | 8 | 2026 |
| Handpiece Headquarters | United States | Maker | BASE290 LED Curing Light · Maxima Advanced 3000 LED Curing Light | 7 | 2024 |
| Premium Plus (Dongguan) Limited | China | Maker | Activator, for polymerization, Dental Curing Light | 2 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | Coltolux Comfort LED Curing Light · COLTOLUX LED CURING LIGHT | 45 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Good Doctors Co., Ltd. | South Korea | Maker | CL-DC20 · CL-DC21 · CL-DP40 (Dr's Light CHOICE) · CL-DP40 (Dr's Light PRIME) · +3 | 5 | 2023 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Curing Light, Broad Spectrum Curing Light, CV-215 G1--G8, 215i, 215i Plus, 216, 218, DTO | 4 | 2022 |
| Dentmate Technology Co. , Ltd. | Taiwan | Maker | LEDEX · LEDEX WL-070 Dental Curing Light · LEDEX WL-070+ ; LEDEX WL-070+ ORTHO · LEDEX WL-090 Dental Curing Light · +1 | 4 | 2022 |
| Garrison Dental Solutions LLC | United States | Maker | LOOP LED Curing Light | 3 | 2024 |
| Bonart Co., Ltd. | Taiwan | Maker | ART-L2 HALOGEN LIGHT CURING UNIT · ART-L3 LED CORDLESS CURING LIGHT · ART-L5 LED CORDLESS CURING LIGHT | 14 | 2017 |
| CAO Group, Inc. | United States | Maker | ASCENT OLX · ASCENT PX · PALMLIGHT 10, MODEL: 001-00030 · SMARTLITE MAX | 13 | 2020 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | Darby · Henry Schein · Maxima Advanced 3000 LED Curing Light | 9 | 2017 |
| Addent, Inc. | United States | Maker | Calset Aluminum Accessory Trays · Calset Composite Warmer | 7 | 2019 |
| Dxm Co., Ltd. | South Korea | Maker | Coltolux LED 2 · Cybird Gold · Cybird LED Curing Light · Cybird Ultra · +5 | 6 | 2020 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| Rolence Ent., Inc. | Taiwan | Maker | elitedent · q-lux · ultra-lite | 5 | 2009 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W · LED TURBO · LED Turbo Pen ; TOP Light Turbo ; TOP Light plus; TOP Light ; Megalight Turbo ; LED 10W ; Mega light CL | 5 | 2007 |
| DMETEC Co., LTD | South Korea | Maker | SKYLIGHT LED CURING LIGHT | 5 | 2017 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Dentmas · LED Curing Light · Model C01 · Model C02 · +1 | 3 | 2017 |
| Dentlight, Inc. | United States | Maker | FUSION Curing Light · FUSION Plus-Grand Curing Light | 3 | 2019 |
| DENTALL Co., Ltd. | South Korea | Maker | B&Lite S | 3 | 2017 |
| Spring Health Products, Inc. | United States | Maker | The CURE | 1 | 1999 |
| Beyes Dental Inc | Canada | Maker | Slimax Series LED Curing Light | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| J. Morita MFG Corp. | Japan | Maker | Root ZX II | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| CMS Dental A/S | Denmark | Maker | FlashMax P3 Cure &Ortho · FlashMax P3 WS · FlashMax P4 OrthoPro · FlashMax P7 LAD | — | — |
| Schott AG | Germany | Maker | Fiber Optic Rod · Light, Fiberoptic, Dental | — | — |
| SCHOTT CR, s.r.o. | Czechia | Maker | Fiber Optic Rod · Light, Fiberoptic, Dental | — | — |
| Allure Ortho | United States | Maker | — | — | — |
| I-Dent Innovations for Dentistry SA | Switzerland | Maker | — | — | — |
| Miller Technical Services | United States | Maker | — | — | — |
| Proguard Health Inc. | United States | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | Glidewell Curing Light Kit | 56 | 2026 |
| Spident Co., Ltd. | South Korea | Foreign exporter | FOCUS | 22 | 2026 |
| Voco GmbH | Germany | Foreign exporter | Caps Warmer · Celalux 3 · Celalux II · TwinWave | 117 | 2026 |
| American Orthodontics | United States | Contract manufacturer | Blue Ray 3 | 44 | 2026 |
| KaVo Dental GmbH | Germany | Contract manufacturer | Satelec Mini LED - 103.8119 | 2 | 2021 |
| DCI International LLC | United States | Manufacturer | Curing Light, LED. G, Woodpecker · Curing Light, Mini LED, Acteon · Kit, Acteon Curing Lt, Cart · Kit, Acteon Curing Lt, S4 Std, Light Gray · +12 | 1 | 2025 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | NM390 AND NM468 | 32 | 2021 |
| Henry Schein, Inc. | United States | Foreign exporter | Smartlite Pro Sleeves Refill | 8 | 2004 |
| Dentamerica | United States | Repacker / relabeler | LITEX | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Halogen Curing Light · TPC LED Curing Light | 3 | 2007 |
| Rmo, Inc. | United States | Manufacturer | Flashmax P4 Light Curing Pen and Flashmax Accessories | 1 | 1990 |
| Vector Research & Development | United States | Repacker / relabeler | Quazar Q-Light · Vector | 1 | 2002 |
| Jersey Dental Supplies | United States | Repacker / relabeler | BLUEPHASE STYLE · VALO Cordless; VALO Cordless Accessory(Battery Charger,Rechargeable Batteries,Light Shield,Bracket Holder,Charging Unit | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | LED Accessory | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | LED Curing Light | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION · Patterson Apex Locator · Patterson Handpiece · Patterson LED Curing Light · +1 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | LED accessory | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Manufacturer | LEDX-PRO | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Led C02-C,C02-S, C02-D · Premium Plus Led Curing Light C01 · Premium Plus Led Curing Light C01-C,C01-S, C01-D · Premium Plus Led Curing Light C02 | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | I LED, I LED II, O-LIGHT, O-LIGHT II | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Fusion Curing Light · REDI SET LED LIGHT | — | — |
| Csy International LLC | United States | Repacker / relabeler | CICADA · J&J ORTHODONTICS | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | D-Lux+ | — | — |
| GoldenDent | United States | Repacker / relabeler | FlashMax · O-Star Curing Light · O-Star Pro Curnig Light · X-Star Curing Light | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | X-Cure, Xlite2NEO, VisionCure | — | — |
| Onvet Medical Canada Inc. | Canada | Manufacturer | ModuLite LED Curing Light System | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Sanicure BV | Netherlands | Foreign exporter | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | — | — |
| Zapalign LLC | United States | Repacker / relabeler | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Brasseler Enlite Curing Light Set | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 18 Jun 2026 | K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. |
| 14 Oct 2025 | K253461 | Demi Pro | Meta Systems Co., Ltd. |
| 5 May 2025 | K242386 | Bluemoon | GENOSS Co., Ltd. |
| 11 Apr 2025 | K243921 | LED Curing Lights (DB686 HALO) | Foshan COXO Medical Instrument Co., Ltd. |
| 10 Apr 2025 | K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited |
| 1 Aug 2024 | K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions LLC |
| 15 Nov 2023 | K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., LTD. |
| 2 Nov 2023 | K233518 | BASE290 LED Curing Light | Handpiece Headquarters |
| 4 Aug 2023 | K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. |
| 22 Dec 2022 | K223142 | Coltolux Comfort LED Curing Light | Dent4You AG |
| 8 Dec 2022 | K220826 | LED Curing Light | Foshan COXO Medical Instrument Co., Ltd. |
| 23 Nov 2022 | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. |
| 16 Sep 2022 | K221194 | LEDEX | Dentmate Technology Co. , Ltd. |
| 22 Feb 2022 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. |
| 1 Mar 2021 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. |
| 14 Aug 2020 | K200775 | LOOP LED Curing Light System | Garrison Dental Solutions LLC |
| 7 Aug 2020 | K200809 | D-LUX+ | DiaDent Group International |
| 13 Feb 2020 | K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. |
| 10 Jan 2020 | K191221 | Cybird LED Curing Light | Dxm Co., Ltd. |
| 9 Jan 2020 | K192009 | LED Curing Light | Ezgo Group, Inc. |
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona, Inc. |
| 3 Jul 2019 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG |
| 29 Apr 2019 | K190627 | VALO Grand Corded | Ultradent Products, Inc. |
| 19 Apr 2019 | K180065 | FUSION Plus Curing Light | Dentlight, Inc. |
| 1 Apr 2019 | K181597 | Le'Pen | Kmihh, Ltd. |
| 29 May 2018 | K173157 | Dr's Light2 | Good Doctors Co., Ltd. |
| 24 Jan 2018 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. |
| 27 Nov 2017 | K161855 | LED Curing Light | Monitex Industrial Co., Ltd. |
| 16 Aug 2017 | K172426 | Clear Blue Digi LED Curing Light | Promident, LLC |
| 8 Aug 2017 | K170529 | Delight, Delight ortho, B&Lite S | DENTALL Co., Ltd. |
| 18 Jul 2017 | K163064 | Demi Ultra | Sybron Dental Specialties |
| 8 Jun 2017 | K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products |
| 7 Apr 2017 | K152192 | LED Curing Light | Monitex Industrial Co., Ltd. |
| 4 Apr 2017 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG |
| 19 Jan 2017 | K163605 | LEDEX WL070+ | Dentmate Technology Co. , Ltd. |
| 22 Aug 2016 | K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited |
| 13 Jul 2016 | K160551 | VALO Grand | Ultradent Products, Inc. |
| 28 Jun 2016 | K153078 | LED Curing Light GT-2000 | Monitex Industrial Co., Ltd. |
| 23 Jun 2016 | K153018 | CELALUX 3 | Voco GmbH |
| 31 Dec 2015 | K150585 | Ascent 3D | CAO Group, Inc. |
| 13 Nov 2015 | K152936 | Sirius Max Dental Diode Curing Light | National Dental, Inc. |
| 24 Aug 2015 | K150205 | LED Curing Light | Monitex Industrial Co., Ltd. |
| 3 Aug 2015 | K140432 | HI-LIGHT, HI-LIGHT PLUS | DENTALL Co., Ltd. |
| 7 Oct 2014 | K133040 | LED CURING LIGHT | Monitex Industrial Co., Ltd. |
| 24 Jul 2014 | K140281 | FLEXI-LUME LED SYSTEM | Epic Medical Concepts & Innovations |
| 11 Apr 2014 | K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | Satelec - Acteon Group |
| 3 Oct 2013 | K131042 | LEDEX | Dentmate Technology Co. , Ltd. |
| 16 Aug 2013 | K130163 | D-LUX | DiaDent Group International |
| 20 Mar 2013 | K123468 | DEMI ULTRA | Sybron Dental Specialties |
| 27 Nov 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Dxm Co., Ltd. |
| 29 Aug 2011 | K110756 | BLUEPHASE STYLE | Ivoclar Vivadent, AG |
| 28 Apr 2011 | K110582 | VALO CORDLESS | Ultradent Products, Inc. |
| 28 Jan 2011 | K102621 | SOLSTICE | Sybron Dental Specialties |
| 24 Feb 2010 | K093751 | CL-DC20, CL-DC21 | Good Doctors Co., Ltd. |
| 7 Dec 2009 | K092951 | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS | Mectron S.P.A. |
| 18 Sep 2009 | K091887 | LED CURING LIGHT, MODEL GT-1500 | Monitex Industrial Co., Ltd. |
| 12 Jun 2009 | K091020 | BLUEPHASE 20I | Ivoclar Vivadent, AG |
| 23 Jan 2009 | K083647 | VALO, MODEL 5919 | Ultradent Products, Inc. |
| 3 Dec 2008 | K082408 | LEDEX, MODEL: WL-070 | Dentmate Technology Co. , Ltd. |
| 21 Nov 2008 | K081287 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHT | Den-Mat Holdings, LLC |
| 13 Nov 2008 | K082971 | BONART ART-L5 LED CORDLESS CURING LIGHT | Bonart Co., Ltd. |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 3 Mar 2008 | K080035 | LED CURING LIGHT | Monitex Industrial Co., Ltd. |
| 20 Dec 2007 | K073518 | FLASHLITE REBEL* | Philips Medical Systems International BV |
| 21 Nov 2007 | K072807 | I LIGHT | Dent'N CO |
| 19 Sep 2007 | K072181 | MINI LED AUTOFOCUS | Satelec |
| 23 Aug 2007 | K071908 | DOCTOR'S LIGHT LED DENTAL CURING LIGHT | Good Doctors Co., Ltd. |
| 10 Aug 2007 | K071722 | DEEP BLUE | E.M.S Electro Medical Systems S.A |
| 26 Jul 2007 | K071251 | DEMI | Sybron Dental Specialties |
| 30 Apr 2007 | K063659 | EASY CURING PEN-STYLE LED CURING LIGHT | Dent Corp. Research & Development |
| 2 Mar 2007 | K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | Apoza Enterprise Co., Ltd. |
| 5 Jan 2007 | K063529 | PENCURE, MODEL VL-7 | J. Morita USA, Inc. |
| 3 Jan 2007 | K062289 | BONART ART-L3 LED CURING LIGHT | Bonart Co., Ltd. |
| 5 Dec 2006 | K063116 | DEMETRON A.2 | Sybron Dental Specialties |
| 28 Nov 2006 | K063003 | AURORA | Parkell, Inc |
| 27 Oct 2006 | K062735 | TUTU 7, MODEL IV-T22 | Invisible Technology Co., Ltd. |
| 18 Sep 2006 | K061658 | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L | DENTALL Co., Ltd. |
| 14 Sep 2006 | K061695 | LED PROLUX 770 | Peng Lim Enterprise Co., Ltd. |
| 23 Jun 2006 | K061395 | CALSET COMPOSITE HEATER | Addent, Inc. |
| 12 Jun 2006 | K061341 | PALMLIGHT 10, MODEL 001-00030 | CAO Group, Inc. |
| 21 Apr 2006 | K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | Monitex Industrial Co., Ltd. |
| 29 Mar 2006 | K052122 | BISCO LED | Bisco, Inc. |
| 21 Oct 2005 | K052349 | AVANTE LED CURING UNIT, MODEL N44 | Pentron Clinical Technologies |
| 28 Sep 2005 | K052593 | FUSION CURING LIGHT | Dentlight, Inc. |
| 20 Sep 2005 | K051782 | BLUEPHASE 16I | Ivoclar Vivadent, AG |
| 28 Jul 2005 | K051780 | JETLITE 5000 | J. Morita USA, Inc. |
| 19 Jul 2005 | K051571 | SKYLIGHT LED CURING LIGHT | DMETEC Co., LTD |
| 18 Jul 2005 | K051545 | L.E. DEMETRON II | Kerr Corporation (Danbury) |
| 25 May 2005 | K051203 | BLUELEX | Monitex Industrial Co., Ltd. |
| 3 Feb 2005 | K050059 | G-LIGHT | GC America Inc. |
| 25 Jan 2005 | K043530 | DVI CURING LIGHT | Designs For Vision, Inc. |
| 3 Jan 2005 | K043302 | NOVA-PULSE | Nova Ranger, Inc. |
| 10 Nov 2004 | K042888 | DEMETRON IDS CURING LIGHT | Sybron Dental Specialties |
| 1 Nov 2004 | K042196 | SAVEDENT BLUE | Denfotex Light Systems, Ltd. |
| 12 Oct 2004 | K042703 | CYBIRD LED CURING LIGHT | Dxm Co., Ltd. |
| 8 Sep 2004 | K042199 | TRANSLUX POWER BLUE | Heraeus Kulzer, LLC |
| 24 Jun 2004 | K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | Dentsply International, Inc. |
| 18 Jun 2004 | K041303 | LED TURBO-PEN | Apoza Enterprise Co., Ltd. |
| 14 Jun 2004 | K040956 | HILUX LEDMAX 3 | First Medical Infection Control Associates, Inc. |
| 28 Apr 2004 | K040808 | MINI L.E.D. OEM MODULE | Satelec |
| 7 Apr 2004 | K040614 | BLUEWAND LED DENTAL CURING WAND SYSTEM | J.L. Blosser, Inc. |
| 25 Mar 2004 | K040618 | LED TURBO | Apoza Enterprise Co., Ltd. |
| 15 Mar 2004 | K040551 | COLTOLUX LED CURING LIGHT | Coltene/Whaledent AG |
| 27 Feb 2004 | K033697 | POWER LED | Dental Products of USA, Inc. |
| 19 Dec 2003 | K033795 | PLASMACURE BXE | Eele Laboratories, LLC |
| 5 Dec 2003 | K033520 | BLUEPHASE | Ivoclar Vivadent, AG |
| 2 Dec 2003 | K033201 | LA500 BLUE LIGHT | Apoza Enterprise Co., Ltd. |
| 27 Oct 2003 | K032099 | SWISS MASTER LIGHT | (Ems Sa) Electro Medical Systems |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec |
| 21 Jul 2003 | K031615 | SLED CURING LIGHT SYSTEM | Dentsply International, Inc. |
| 10 Jun 2003 | K030811 | COOL CURE | Samm, Inc. |
| 10 Jun 2003 | K030641 | CONTEC LIGHT | Dentaurum |
| 24 Apr 2003 | K030568 | RADII | Southern Dental Industries, Inc. |
| 10 Mar 2003 | K024374 | RMO PLASMA CURING LIGHT | Lokki Lasers Medicaux |
| 17 Jan 2003 | K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | Philips Medical Systems International BV |
| 10 Jan 2003 | K023721 | BONART ART-L2 LIGHT CURING UNIT | Bonart Co., Ltd. |
| 9 Jan 2003 | K023652 | REMECURE MODEL CL 15E | Remedent NV |
| 30 Dec 2002 | K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | Rolence Ent., Inc. |
| 18 Oct 2002 | K022862 | TRANSCURE, MODEL 2910 | Kinetic Instruments, Inc. |
| 2 Oct 2002 | K022265 | LIGHT TIP | Svenska Dental Instruments AB |
| 27 Aug 2002 | K020057 | PALMLIGHT | CAO Group, Inc. |
| 20 Aug 2002 | K022184 | FLASH-LITE LED DENTAL CURING LIGHT | Philips Medical Systems International BV |
| 27 Jun 2002 | K021797 | L.E.DEMETRON | Sybron Dental Specialties |
| 12 Jun 2002 | K020884 | EXCELLITE LIGHT CURE UNIT | Rolence Ent., Inc. |
| 12 Jun 2002 | K020877 | EXCELLITE TURBO LIGHT CURE UNIT | Rolence Ent., Inc. |
| 12 Jun 2002 | K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | Rolence Ent., Inc. |
| 30 May 2002 | K021374 | TOESCO AQUA BLUE LED LIGHT CURING DEVICE | Toei Electric Co., Ltd. |
| 29 Mar 2002 | K020267 | OPTILUX CURING LIGHTS | Sybron Dental Specialties |
| 21 Mar 2002 | K020091 | OPTILUX 501 | Kerr Corporation (Danbury) |
| 4 Feb 2002 | K014179 | DEMETRON LC | Sybron Dental Specialties |
| 29 Jan 2002 | K020171 | COOLBLU2 DENTAL RESIN CURING DEVICE | Dental Systems.Com, Inc. |
| 14 Jan 2002 | K013500 | KAVO POLYLUX II | Kavo America |
| 22 Oct 2001 | K013277 | ASTRALIS 7, MODEL 557545 | Ivoclar Vivadent, AG |
| 19 Oct 2001 | K013275 | ASTRALIS 10, MODELS # 559588, 561859 | Ivoclar Vivadent, AG |
| 2 Oct 2001 | K012946 | SUNLITELED MODEL #2810 | Kinetic Instruments, Inc. |
| 30 Aug 2001 | K012341 | TRANSLUX ENERGY | Heraeus Kulzer, LLC |
| 7 Aug 2001 | K012134 | GC E-LIGHT | GC America Inc. |
| 16 May 2001 | K011154 | ELIPAR FREELIGHT | Espe Dental AG |
| 5 Apr 2001 | K010133 | VERSALUX | Centrix, Inc. |
| 6 Feb 2001 | K003383 | PALMLIGHT | Ultradent Products, Inc. |
| 11 Jan 2001 | K003683 | AVANTE CURELIGHT | Jeneric/Pentron, Inc. |
| 20 Dec 2000 | K002925 | COOLBLU CURING LIGHT | Dental Systems.Com, Inc. |
| 28 Nov 2000 | K002991 | ZAP DUAL CURING LIGHT | Soft-Core Texas, Inc. |
| 19 Oct 2000 | K002566 | LUMALITE CURE LIGHT, MODEL 2100 | Lumalite, Inc. |
| 10 Oct 2000 | K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | Rolence Enterprise, Inc. |
| 15 May 2000 | K000078 | JETLITE 4000 | J. Morita USA, Inc. |
| 12 Apr 2000 | K000426 | VIP- VARIABLE INTENSITY POLYMERIZER | Bisco, Inc. |
| 27 Mar 2000 | K000393 | NOVA CORDLESS CURING LIGHT | Nova/Da Vinci Systems, Inc. |
| 13 Jan 2000 | K994048 | PORTABLE LIGHT CURING UNIT | Gregory S. Jacob, D.D.S. |
| 12 Jan 2000 | K994028 | FLIPO XENON CURING LIGHT | Lokki |
| 1 Nov 1999 | K993223 | RAPICURE 200 (CURING AND WHITENING LIGHT) | Mediphotonix, LC |
| 29 Sep 1999 | K992728 | SPRING POWERLITE 2000 | Spring Health Products, Inc. |
| 30 Aug 1999 | K992357 | EASY-CURE (CURING AND WHITENING LIGHT) | Ics of North America, Inc. |
| 27 Aug 1999 | K992236 | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA | Lysta A/S |
| 20 Jul 1999 | K991865 | Q-LITE 75 LIGHT CURE UNIT | Rolence Enterprise, Inc. |
| 19 Jul 1999 | K991863 | CUTE-LITE I LIGHT CURE UNIT | Rolence Enterprise, Inc. |
| 23 Apr 1999 | K991138 | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA | Lysta A/S |
| 25 Feb 1999 | K984247 | ELIPAR TRILIGHT | Espe Dental AG |
| 24 Aug 1998 | K982615 | AIRDENT RADIANCE CURING LIGHT | Duerr Dental SE |
| 6 Jan 1998 | K974369 | APOLLO 9500 | Ion Laser Technology |
| 29 Aug 1997 | K972355 | 3M AURORA SYSTEM | 3M Company |
| 10 Jul 1997 | K972006 | ACTA OEM MODULE | Interactive Consulting, Inc. |
| 4 Jun 1997 | K970506 | HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT | Benlioglu Dental Ithalat, Inc. |
| 18 Mar 1997 | K964524 | ILT ARGON HP | Ion Laser Technology |
| 24 Oct 1996 | K963110 | JETLITE | J. Morita USA, Inc. |
| 31 Jul 1996 | K961735 | ACTA | Satelec |
| 15 Apr 1996 | K960364 | CU-200 LIGHT CURE UNIT | Rolence Enterprise, Inc. |
| 15 Apr 1996 | K960351 | Q-LUX LIGHT CURE UNIT | Rolence Enterprise, Inc. |
| 15 Feb 1996 | K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | Ion Laser Technology |
| 4 Jan 1996 | K955763 | OPTILUX 400 | Demetron Research Corp. |
| 2 Jan 1996 | K955759 | LITEX 680 | Dentamerica |
| 21 Sep 1995 | K954061 | POLY-LITE MODEL 1000 | Pro-Den Systems, Inc. |
| 22 Jun 1995 | K952423 | CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 | Rolence Enterprise, Inc. |
| 31 May 1995 | K951465 | SUNLITE 1275 | Fen Dental Mfg., Inc. |
| 24 May 1995 | K950106 | COLTOLUX LIGHT METER | Coltene/Whaledent AG |
| 24 May 1995 | K945698 | COLTOLUX 3, COLTOLUX 4 | Coltene/Whaledent AG |
| 5 May 1995 | K951425 | SPECTRUM CURING LIGHT POLYMERIZATION UNIT | Dentsply Intl., Inc. |
| 2 Jun 1994 | K942199 | CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 | Rolence Enterprise, Inc. |
| 27 May 1994 | K942198 | CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 | Rolence Enterprise, Inc. |
| 6 Jan 1994 | K934746 | 3M CURING LIGHT XL1500 | 3M Company |
| 23 Apr 1993 | K930086 | ORTHOLUX XT | 3M Company |
| 25 Nov 1992 | K924812 | 3M CURING LIGHT XL 3000 | 3M Company |
| 23 Dec 1991 | K912994 | COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE | Wilde-USA, Inc. |
| 16 Dec 1991 | K913980 | HELIOLUX | Ivoclar North America, Inc. |
| 15 Mar 1991 | K910068 | SPECTRAMAT | Ivoclar North America, Inc. |
| 11 Mar 1991 | K905543 | LARES APOLLO CS/CP/C | Lares Research |
| 13 Jul 1990 | K901908 | HELIOLUX VISIBLE CURING LIGHT | Ivoclar North America, Inc. |
| 7 May 1990 | K900135 | CU-75 VISIBLE LIGHT-CURING UNIT | Kab Gloves Unltd. |
| 2 Apr 1990 | K895085 | WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT | Lustgarten Multi-Tech International, Inc. |
| 21 Aug 1989 | K892517 | TULUX-FILTER | Espe GmbH (Us) |
| 14 Jun 1989 | K892456 | KULZER TRANSLUX EC | Kulzer, LLC |
| 17 Mar 1989 | K884222 | CURING LIGHT COVER | Steri-Shield Products, Inc. |
| 6 Sep 1988 | K882145 | PHOTO-CURING LIGHT | Dentsply Intl., Inc. |
| 7 Apr 1988 | K880392 | ORTHOLUX VISIBLE LIGHT CURING UNIT | Unitek Corp. |
| 26 Mar 1986 | K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Almore Intl., Inc. |
| 9 Jul 1985 | K851915 | CURING LIGHT | Technology, Inc. |
| 21 Dec 1984 | K844351 | OPTI-LITE | Innovators, Inc. |
| 11 Dec 1984 | K844325 | COE-LITE POLYMERIZATION UNIT | Coe Laboratories, Inc. |
| 4 Dec 1984 | K843823 | TRANSLUX CL | Kulzer, LLC |
| 31 Aug 1983 | K832320 | PRISMA III | Dentsply Intl., Inc. |
Showing the 200 most recent of 214.
Official records: FDA product classification for EBZ · 21 CFR 872.6070.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026