Instruments for functional explorations and therapeutic interventionsDental stomatology instrumentsInstruments for dental treatment units
Instruments for dental treatment units - hardware accessories
EMDN code Z12110180
Manufacturers registered in Europe (EUDAMED) 31
- 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) 64
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 |
|---|---|---|---|
| Midmark Corp. Present in Europe in other categories | United States | Midmark | registered |
| Ls Enterprises, Inc. | – | Forest | registered |
| DCI International, LLC Present in Europe in other categories | United States | DCI Edge | registered |
| TAKARA BELMONT CORP. Present in Europe in other categories | United States | Bel-Halo LED Bel-Nova LED CLESTA LED DENTAL LIGHT Bel-Halo Dental Light | registered |
| DENTIS CO. ,LTD Present in Europe in other categories | South Korea | LUVIS-C200 Series LUVIS-C600 Series LUVIS-C500 Series LUVIS-C700 Series LUVIS-C300 Series LUVIS-C400 Series | registered |
| Dentalez Alabama, Inc. | – | Dentalez | registered |
| A-Dec, Inc. | United States | A-dec | K893044 (1989) |
| F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA | – | FARO | registered |
| ZYRIS, INC. | – | Isolite, i2 Accessories Maintenance Kit | registered |
| Medfruition Electronics Technology Co., Ltd Present in Europe in other categories | China | Dental Operating Light | registered |
| JMU DENTAL, INC | – | JMU | registered |
| Engle Dental Systems, LLC | United States | Post Mount LED Light Post Mount LED Light for Non-Engle 360 LED Light Utility Center Mount LED Light Utility Center Mount LED Light for Non-Engle Ceiling Mount LED Light | registered |
| Aseptico, Inc. Present in Europe in other categories | United States | Aseptico | registered |
| Foshan COXO Medical Instrument Co.,Ltd. Present in Europe in other categories | China | COXO | registered |
| CEFLA SOCIETA' COOPERATIVA | – | CEFLA | registered |
| DEN-MAT HOLDINGS, LLC | United States | ViziLite® | registered |
| Digital Doc LLC | United States | LuM | registered |
| Ergonomic Products, Inc. | United States | – | registered |
| Oralkleen, LLC | United States | OralKleen™ | registered |
| AIOBIO CO.,LTD | South Korea | AIOBIO | registered |
| DENTAL MONITORING | France | LED Adapter | registered |
| Dxm Co., Ltd. Present in Europe in other categories | United States | D6 HEXA | registered |
| Megagen Implant Co. Ltd Present in Europe in other categories | South Korea | Dental Light | registered |
| Proma, Inc. | United States | Proma | registered |
| Safari Dentaire Inc | – | Dental Operating Light | registered |
| Addent, Inc. | United States | – | K072309 (2007) |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | – | registered |
| Aopu Lighting (Jinyun) Co., Ltd. | China | – | registered |
| Ascentcare Dental Products | United States | – | registered |
| BEAVERSTATE DENTAL, INC. | United States | – | registered |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | – | registered |
| Chuan Fu Medical Instrument Co., Ltd | Taiwan | – | registered |
| DENTAL TECHNOLOGIES, INC. | United States | – | registered |
| DENTSPLY SIRONA INC | United States | – | registered |
| DEXTA CORP. | United States | – | registered |
| DHEF INC. Present in Europe in other categories | Taiwan | – | registered |
| DNTLWORKS EQUIPMENT CORP. | United States | – | registered |
| DOIFF Co., Ltd. | South Korea | – | registered |
| DTE Oregon, Inc | United States | – | registered |
| Dentalez Group | United States | – | registered |
| Dentozone Corporation | South Korea | – | registered |
| Dongguan Wanjin Industrial Co., Ltd | China | – | registered |
| EPDENT Co., Ltd. | South Korea | – | registered |
| Firstar Dental Company Present in Europe in other categories | United States | – | registered |
| Forefront (Xiamen) Medical Devices Co., Ltd. | China | – | registered |
| GAVIN BIOTECHNOLOGY CO.,LTD | China | – | registered |
| Guangzhou Ajax Medical Equipment Co., Ltd. Present in Europe in other categories | China | – | registered |
| HENAN BAISTRA MEDICAL DEVICES LIMITED | China | – | registered |
| Hangzhou Wise Medical Device Co.,Ltd | China | – | registered |
| J.MORITA MFG.CORP. Present in Europe in other categories | Japan | – | registered |
| Kuang Yeu Co. Ltd | Taiwan | – | registered |
| Lakong Medical Devices Co., Ltd. Present in Europe in other categories | China | – | registered |
| MANUFACTURERA DENTAL CONTINENTAL | Mexico | – | registered |
| MASTERCRAFT DENTAL CO. OF TEXAS | United States | – | registered |
| Olsen Indústria e Comércio S/A Present in Europe in other categories | Brazil | – | registered |
| SINOL DENTAL LIMITED | China | – | registered |
| Safari Dental, Inc. | Canada | – | registered |
| Shanghai Greeloy Industry Co., Ltd | China | – | registered |
| Shenzhen Denco Medical Co., Ltd Present in Europe in other categories | China | – | registered |
| Shenzhen Rogin Medical Co., Ltd Present in Europe in other categories | China | – | registered |
| Silfradent srl Present in Europe in other categories | Italy | – | registered |
| Summit Dental Systems LLC. Present in Europe in other categories | United States | – | registered |
| XENOSYS CO., LTD. Present in Europe in other categories | South Korea | – | registered |
| whr Hossinger Kunststofftechnik GmbH | Germany | – | registered |
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