Instruments for functional explorations and therapeutic interventionsDental stomatology instrumentsVarious dental stomatology instruments
Cold light dental equipment
EMDN code Z12119003
Manufacturers registered in Europe (EUDAMED) 22
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 86
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| COLTENE/WHALEDENT INC Present in Europe in other categories | United States | Coltolux SPEC 3 | K040551 (2004) |
| DENTMATE TECHNOLOGY CO., LTD. Present in Europe in other categories | Taiwan | LEDEX | K221194 (2022) |
| IVOCLAR VIVADENT AKTIENGESELLSCHAFT | – | Bluephase G4 BLUEPHASE STYLE Bluephase PowerCure Bluephase EasyCure BLUEPHASE STYLE 20I | registered |
| ASI MEDICAL, INC. | United States | Advanced Dental System Advanced Endodontic System | registered |
| DEN-MAT HOLDINGS, LLC | United States | Sapphire® Plus Flashlite® DenMat® MAGNA 4.0 | K081287 (2008) |
| BENCO DENTAL SUPPLY CO. | – | SOLEIL BENCO | registered |
| Kerr Corporation Present in Europe in other categories | United States | Light Guide Demi Plus Demi Ultra Demi | K163064 (2017) |
| DiaDent Group International | South Korea | D-LUX+ D-Lux | K200809 (2020) |
| GARRISON DENTAL SOLUTIONS, L.L.C. | United States | Loop™ Loop™ Calibration and Charging Base | K241238 (2024) |
| MAXILL, INC. | United States | LUMAX REPLACEMENT BATTERY LUMAX REPLACEMENT ACRYLIC PROTECTIVE LIGHT SHIELD LUMAX REPLACEMENT HEAD LUMAX LED CURING LIGHT LUMAX CURING LIGHT METER LUMAX ACRYLIC PROTECTIE LIGHT SHIELD | registered |
| PATTERSON DENTAL SUPPLY, INC. | United States | Patterson® PATTERSON | registered |
| Premium Plus International Limited | China | Premium Plus International Limited Premium Plus | K153514 (2016) |
| USA THINK INC. | – | First Medica | registered |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | Slimax-C Plus | registered |
| TPC ADVANCE TECHNOLOGY, INC. | – | TPC | registered |
| Bonart Co., Ltd. | United States | LED CURING LIGHT L3 LIGHT GUIDE LIGHT CURING UNIT L2/L5 LIGHT GUIDE L5 Charging Dock LED CORDLESS CURING LIGHT | K082971 (2008) |
| Dent4You AG Present in Europe in other categories | Switzerland | Coltolux Comfort | K223142 (2022) |
| Good Doctors Co., Ltd. Present in Europe in other categories | South Korea | Dr's Light PRIME Drs Light Claver Guide-cap_Drs Light Claver Battery_Drs Light Claver Dr's Light Dr's Light CHOICE | K223507 (2023) |
| META SYSTEMS CO., LTD. | South Korea | Demi Pro | K253461 (2025) |
| Satelec | United States | ACTEON | K072181 (2007) |
| CAO Group, Inc. Present in Europe in other categories | United States | Ascent OL5 Barrier Sleeve Ascent PX Curing Light Ascent PX Barrier Sleeve Ascent PX Protective Shield Ascent OL5 Curing Light Ascent PX Replacement Wand | K150585 (2015) |
| Parkell, Inc. Present in Europe in other categories | United States | Parkell® Aurora™ | K063003 (2006) |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Luminary-3D Dental Luminary by 3D Dental LL-LED-II | registered |
| Dentall co.,Ltd. Present in Europe in other categories | United States | B&Lite S | K170529 (2017) |
| Kulzer, Inc. | United States | Starlight pro | K892456 (1989) |
| Rmo, Inc. | – | FlashMax | registered |
| DENTAMERICA, INC. | United States | LITEX | K955759 (1996) |
| Dentsply De Trey GmbH | – | SmartLite Focus | registered |
| 3M UNITEK CORPORATION | – | 3M™ Ortholux™ Ortholux™ Luminous | registered |
| Foshan Cicada Dental Instrument Co., Ltd. Present in Europe in other categories | China | CICADA | K192233 (2020) |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| Dentlight Inc. | United States | FUSION Curing Light FUSION Grand Curing Light FUSION Plus Curing Light | K180065 (2019) |
| Dxm Co., Ltd. Present in Europe in other categories | United States | Cybird SPEC3 | K191221 (2020) |
| Vista Dental | – | Valiant Curing Light PinkWave Kit | registered |
| DENTRONIX INC | – | Dentronix | registered |
| Flight Dental Systems | – | FLIGHT DENTAL SYSTEMS | registered |
| Foshan COXO Medical Instrument Co.,Ltd. Present in Europe in other categories | China | COXO | K243921 (2025) |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Lumira™ LED Curing Light | registered |
| S.D.I. USA, INC. | Australia | RADII | registered |
| B& L Biotech, inc. Present in Europe in other categories | South Korea | B&Lite S | registered |
| Changzhou Sifary Medical Technology Co., Ltd. Present in Europe in other categories | China | Eighteeth | K221152 (2022) |
| Cole Instruments Inc | United States | Graft Board Round LED Backlight | registered |
| Dmetec.Co., Ltd. | United States | SkyLight | K051571 (2005) |
| Globalmed Holdings, LLC | United States | Variable Polarizing Hood | registered |
| JOHNSON-PROMIDENT | – | Clear Blue | registered |
| ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | – | LEDX-PRO | registered |
| PEARSON DENTAL SUPPLIES, INC. | – | Vivid TurboCure | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA | registered |
| Prismatik Dentalcraft, Inc | United States | Glidewell™ | registered |
| SAFCO DENTAL SUPPLY CO. | United States | Safco Influx LED Curing Light | registered |
| ALLURE ORTHO | United States | – | registered |
| Addent, Inc. | United States | – | K061395 (2006) |
| CMS DENTAL A/S | Denmark | – | registered |
| DENTSPLY SIRONA INC | United States | – | K191865 (2019) |
| DHEF INC. Present in Europe in other categories | Taiwan | – | registered |
| Doctor Devices | Pakistan | – | registered |
| Ezgo Group, Inc. | United States | – | K192009 (2020) |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| GENOSS CO., Ltd. | South Korea | – | K242386 (2025) |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| GreenMark Biomedical Inc. | United States | – | registered |
| Guangzhou Rebornendo Medical Instrument Co., Ltd. Present in Europe in other categories | China | – | K253131 (2026) |
| Handpiece Headquarters | United States | – | K233518 (2023) |
| I-Dent Innovations for Dentistry SA | Switzerland | – | registered |
| Inter-Med/Vista Dental Products | United States | – | K170101 (2017) |
| Intermed Group, Inc. Present in Europe in other categories | United States | – | registered |
| J.MORITA MFG.CORP. Present in Europe in other categories | Japan | – | registered |
| Kmihh, Ltd. | Israel | – | K181597 (2019) |
| Mainline Medical Dental Supply | Canada | – | registered |
| Meta Biomed, Inc. | United States | – | registered |
| Miller Technical Services | United States | – | registered |
| Nanchang Micare Medical Equipment Co.,Ltd Present in Europe in other categories | China | – | registered |
| Patterson Companies, Inc. | United States | – | registered |
| Premium Plus (Dongguan) Limited | China | – | K250009 (2025) |
| Proguard Health, Inc | United States | – | registered |
| Promident, LLC | United States | – | K172426 (2017) |
| Rolence Ent., Inc. | Taiwan | – | K023545 (2002) |
| SCHOTT AG | Germany | – | registered |
| SCHOTT CR, s.r.o. | Czechia | – | registered |
| SYBRON DENTAL SPECIALTIES, INC. | United States | – | K063116 (2006) |
| Sanicure BV | Netherlands | – | registered |
| Satelec - Acteon Group | United States | – | K131906 (2014) |
| Shandong Deman Medical Equipment Group Co., Ltd. Present in Europe in other categories | China | – | registered |
| Soher Med Limited | Hong Kong SAR China | – | registered |
| Solventum US LLC Present in Europe in other categories | United States | – | registered |
| W&H Dentalwerk Buermoos GmbH | Austria | – | registered |
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