Curing lights: manufacturers and brands
52 companies make or specify curing lights among the 87 that list one with FDA, under 228 brand and model names. FDA has issued 214 510(k) clearances in this category, 14 of them in the last five years.
510(k) clearances per year, 1976–2026
Curing light manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| 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 | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where curing lights are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ | 2 | 872.6070 | 52 | 214 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jun 2026 | K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 14 Oct 2025 | K253461 | Demi Pro | Meta Systems Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 5 May 2025 | K242386 | Bluemoon | GENOSS Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 11 Apr 2025 | K243921 | LED Curing Lights (DB686 HALO) | Foshan COXO Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 10 Apr 2025 | K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | EBZ Ultraviolet Activator for Polymerization |
| 1 Aug 2024 | K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions LLC | EBZ Ultraviolet Activator for Polymerization |
| 15 Nov 2023 | K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., LTD. | EBZ Ultraviolet Activator for Polymerization |
| 2 Nov 2023 | K233518 | BASE290 LED Curing Light | Handpiece Headquarters | EBZ Ultraviolet Activator for Polymerization |
| 4 Aug 2023 | K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 22 Dec 2022 | K223142 | Coltolux Comfort LED Curing Light | Dent4You AG | EBZ Ultraviolet Activator for Polymerization |
| 8 Dec 2022 | K220826 | LED Curing Light | Foshan COXO Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 23 Nov 2022 | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 16 Sep 2022 | K221194 | LEDEX | Dentmate Technology Co. , Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 22 Feb 2022 | K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 1 Mar 2021 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 14 Aug 2020 | K200775 | LOOP LED Curing Light System | Garrison Dental Solutions LLC | EBZ Ultraviolet Activator for Polymerization |
| 7 Aug 2020 | K200809 | D-LUX+ | DiaDent Group International | EBZ Ultraviolet Activator for Polymerization |
| 13 Feb 2020 | K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 10 Jan 2020 | K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 9 Jan 2020 | K192009 | LED Curing Light | Ezgo Group, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 3 Jul 2019 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | EBZ Ultraviolet Activator for Polymerization |
| 29 Apr 2019 | K190627 | VALO Grand Corded | Ultradent Products, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 19 Apr 2019 | K180065 | FUSION Plus Curing Light | Dentlight, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 1 Apr 2019 | K181597 | Le'Pen | Kmihh, Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 29 May 2018 | K173157 | Dr's Light2 | Good Doctors Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 24 Jan 2018 | K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 27 Nov 2017 | K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 16 Aug 2017 | K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | EBZ Ultraviolet Activator for Polymerization |
| 8 Aug 2017 | K170529 | Delight, Delight ortho, B&Lite S | DENTALL Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 18 Jul 2017 | K163064 | Demi Ultra | Sybron Dental Specialties | EBZ Ultraviolet Activator for Polymerization |
| 8 Jun 2017 | K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | EBZ Ultraviolet Activator for Polymerization |
| 7 Apr 2017 | K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 4 Apr 2017 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | EBZ Ultraviolet Activator for Polymerization |
| 19 Jan 2017 | K163605 | LEDEX WL070+ | Dentmate Technology Co. , Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 22 Aug 2016 | K153514 | Premium Plus C01/C02 LED Curing Light | Premium Plus International Limited | EBZ Ultraviolet Activator for Polymerization |
| 13 Jul 2016 | K160551 | VALO Grand | Ultradent Products, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 28 Jun 2016 | K153078 | LED Curing Light GT-2000 | Monitex Industrial Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 23 Jun 2016 | K153018 | CELALUX 3 | Voco GmbH | EBZ Ultraviolet Activator for Polymerization |
| 31 Dec 2015 | K150585 | Ascent 3D | CAO Group, Inc. | EBZ Ultraviolet Activator for Polymerization |