Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsInstruments for endoral radiology
Endoral radiology equipment
EMDN code Z11030401
Manufacturers registered in Europe (EUDAMED) 28
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 157
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 Midmark PREVA IntraOral Dental X-ray System Midmark PREVA 2.0 IntraOral Dental X-ray System Midmark VETPRO IntraOral Dental X-ray System PREVA 2.0, MOBILE RETROFIT KIT PREVA, 66" REACH, DEUTSCH | registered |
| SIRONA DENTAL, INC. | – | AimRight Holder Universal Holders AimRight Intraoral Sensor Holder SCHICK ELITE Schick AE | registered |
| Directa AB | Sweden | TrollByte TrollBag Directa Cheek Retractor Camera Sleeve | registered |
| CLIKTECH LLC | United States | 5 Piece ClikRay (TM) Kodak Size 2 Holder V-Series Size 1.5 Anterior SAGE Bite Block 3-Pack XL-Series Size 2 Anterior BLUE Bite Block 3-Pack Dexis/ShaRing Litening Rods Kit 8 Bite Blocks Size 1.5 ClikStik, IRing, IRod, and 8 Bite Blocks size 1&2 ClikRay H2 Holder 5-Pack | registered |
| Dentsply Intl. Present in Europe in other categories | United States | RINN® Universal Xios | registered |
| DuPhaMed B.V. | Netherlands | Cefla DenBite Care Stream Dental Flow Dental | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Visionary by 3D Dental Essentials by 3D Dental Luminary by 3D Dental | registered |
| CEFLA SOCIETA' COOPERATIVA | – | myray NewTom Castellini Anthos Stern Weber | registered |
| TIDI PRODUCTS, LLC | United States | TIDISHIELD Patterson Dental, X-Ray Sensor Sheath Sirona TIDI GEM Henry Schein | registered |
| Techno-Aide, Inc. | United States | Techno-Aide | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein Carina | K801079 (1980) |
| OWANDY RADIOLOGY | – | Owandy-RX DC Owandy-RX PRO | registered |
| Steri-Shield Products, Inc. | United States | Steri-Shield | registered |
| TAKARA BELMONT CORP. Present in Europe in other categories | United States | PHOT-X IIs Model 505 BELRAY II PHOT-X II, MODEL 303 | K141293 (2014) |
| Carestream Health, Inc. Present in Europe in other categories | United States | CS 2200 CS 2100 CS 8000C SIZE B COLLIMAT. FOR I/O XRAY UNITS CG797 SIZE C COLLIMAT. FOR I/O XRAY UNITS | registered |
| PLASDENT CORPORATION | United States | Plasdent | registered |
| Aribex, Inc. | United States | NOMAD™ handheld X-ray system NOMAD Pro 2™ Packaged System, Kavo Nomad Pro2, GBL Packaged System, KaVo Nomad Pro2, CA Packaged System, Kavo Nomad Pro2, US | K173319 (2017) |
| JMU DENTAL, INC | – | JMU | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA | registered |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | Intraoral Dental Digital Imaging Sensor EVOLVE SENSOR EAGLE X-RAY | K233395 (2024) |
| Young Innovations, Inc. | United States | Defend Panoramic | registered |
| Maquira Industria de Produtos Odontologicos S/A | Brazil | Maquira Cartridge (box) containing one pot with Digital Sensor Cone Positioner | registered |
| BLUO ELECTRONICS SRL | – | PantOs 16 xp IntraOs DG PantOs DG xp PantOs 16 xp Ceph IntraOs 70 FONA XDC | registered |
| XZEAL TECHNOLOGIES, INC. | – | XZeal Z70 Wall VET XZeal Z70 Wall XZeal Z70 Mobile VET XZeal Z70 Mobile | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| DENTAMERICA, INC. | United States | APIXIA DIGIREX | K060640 (2006) |
| Guangzhou Ajax Medical Equipment Co., Ltd. Present in Europe in other categories | China | ADS | K252110 (2026) |
| Guilin Woodpecker Medical Instrument Co., Ltd. Present in Europe in other categories | China | WOODPECKER DTE | K251438 (2025) |
| NANORAY CO.,LTD Present in Europe in other categories | South Korea | Portable Dental X-ray (R2 Port-X with Back scatter shield) Portable Dental X-ray (CS 2300P) Portable Dental X-ray (NR-F350 with Back scatter shield) Portable Dental X-ray (R2 Port-X without Back scatter shield) Portable Dental X-ray (CS 2400P) Portable Dental X-ray (NR-F350 without Back scatter shield) | K201800 (2020) |
| YOUNG PS ACQUISITION, LLC | – | Panoramic Corporation | registered |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | DURAY | registered |
| Denterprise International, Inc. | United States | Xray2Go Smil-O-Ray MOBILE-X Xray2Go Mini | K180561 (2018) |
| ImageWorks | – | INTRASKAN DC | registered |
| Dental Health Products Inc | – | Health-Tec/DHP PSP Barrier Envelopes Health-Tec/DHP Bite Wing Tabs Health-Tec/DHP Disposable Dappen Dishes | registered |
| Gendex Corp. | United States | Gendex eXpert DC™ intraoral x-ray system | K935046 (1994) |
| HAGER WORLDWIDE, INC. Present in Europe in other categories | United States | Salibag Disposable Pouch for CCD/SLB-LL Soft Bitewing Flaps Salibag Disposable Pouch for CCD/SLB-L | registered |
| REMEDI CO.,LTD. Present in Europe in other categories | South Korea | REMEX T100 MobileX Portable X-Ray System REMEX GR100 | K240759 (2024) |
| Dpm USA Corp. | United States | Bi-Image-X Evolution Mobile Bi Image X-Evolution Wall | registered |
| ECOTRON Present in Europe in other categories | South Korea | – | K221233 (2022) |
| Hdx Will Corp. Present in Europe in other categories | South Korea | STAR-X Xcam | K192700 (2019) |
| Radiotecnología Industrial, S.A. de C.V. | Mexico | BI Image-X | K160458 (2016) |
| Shenzhen Xpectvision Technology Co.,Ltd. Present in Europe in other categories | China | XLinearVision XpectVision | K233914 (2024) |
| TEMREX CORPORATION | United States | TEMREX BITEWING LOOPS TEMREX BITE WING TABS | registered |
| Air Techniques, Inc. Present in Europe in other categories | United States | Provecta S-Pan Bite Block Covers | registered |
| Athlos Oy | Finland | DC-Air™ Holder Pack | registered |
| B. Ali Impex | Pakistan | ECCO | registered |
| Coramex, S.A. | United States | Corix 70 | K031802 (2003) |
| DRTECH Corporation Present in Europe in other categories | South Korea | XERO-alpha | K242591 (2024) |
| Lucas Lifecare, LLC | United States | LifeRay | K241305 (2024) |
| Osstem Implant Co., Ltd._Gasan Branch | – | Osstem | registered |
| PICOPACK Inc. | South Korea | WeRay | K241963 (2024) |
| Poskom Co., Ltd. Present in Europe in other categories | South Korea | POSKOM Co., Ltd. | registered |
| Radmedix, LLC | United States | Acuity DX+ | registered |
| Rolence Enterprise Co. , Ltd. Present in Europe in other categories | Taiwan | Rolence | K172928 (2018) |
| SCOTT'S DENTAL SUPPLY L.L.C. | – | X-RAY MOUNTS QUICK TEAR (1000/ROLL) | registered |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| VSI Co., Ltd. Present in Europe in other categories | South Korea | CLAROX | K221286 (2022) |
| Vista Dental | – | Vista Bite Wing Tabs | registered |
| 3Dio | United States | – | K223780 (2023) |
| ACCOMPANY SURGICAL | Pakistan | – | registered |
| ACME ENTERPRISES | Pakistan | – | registered |
| ADS DENTAL SYSTEM INC. | United States | – | registered |
| Acheron Instruments (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| BGSS COMPANY ASIA LIMITED | China | – | registered |
| Bh Medical Products Co., Ltd. | China | – | registered |
| BiometerPlus USA, Inc. | United States | – | registered |
| CARWILD CORPORATION | United States | – | registered |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | – | registered |
| Comfort Surgical Instruments | Pakistan | – | registered |
| Confident Instruments | Pakistan | – | registered |
| Coomex Sources Co. Ltd. | China | – | registered |
| DENTSPLY SIRONA INC | United States | – | registered |
| DHEF INC. Present in Europe in other categories | Taiwan | – | registered |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | – | registered |
| DONGGUAN YILONG MEDICAL SUPPLIES CO.. LTD. Present in Europe in other categories | China | – | registered |
| Daddy D Pro Present in Europe in other categories | Pakistan | – | registered |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | – | registered |
| Denta Craft Instruments | Pakistan | – | registered |
| Dental Brands for Less | Canada | – | registered |
| Energy Resources International Co., Ltd. Hsinchu Branch | Taiwan | – | K213282 (2022) |
| FREDRICKS/PLASTEEL CORP. | United States | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Fona S.R.L | Italy | – | K222274 (2022) |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Guangzhou Four E's Scientific Co., Ltd. Present in Europe in other categories | China | – | registered |
| Guangzhou Xinuo Technology Co., Ltd | China | – | registered |
| Guilin Refine Medical Instrument Co., Ltd. Present in Europe in other categories | China | – | K254018 (2026) |
| HI MEDICAL CO., LTD. | South Korea | – | registered |
| HUANGHUA DK DENTAL CO., LTD | China | – | registered |
| Hangzhou Fushan Medical Appliance Co., Ltd. | China | – | registered |
| Huanghua Promisee Dental Co., Ltd | China | – | registered |
| Hubei Guarddent Medical Technology Co.,Ltd | China | – | registered |
| Integra LifeSciences Corporation Present in Europe in other categories | United States | – | registered |
| Intermed Group, Inc. Present in Europe in other categories | United States | – | registered |
| Iray Imaging Technology (Haining) Limited | China | – | registered |
| Iray Technology Taicang , Ltd. | China | – | K223010 (2023) |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Jinyuan medical equipment(tianjin)co.,ltd | China | – | registered |
| Kash Sales Inc. | Canada | – | registered |
| LLD Care d.o.o. | Croatia | – | registered |
The 100 most active manufacturers are shown, out of 157.
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Related categories
- Systems for intraoral digital videoradiography26 manufacturers
- Instruments for endoral radiology - consumables2 manufacturers
- Instruments for digital endoral radiology - medical device software1 manufacturer
- Instruments for digital endoral radiology - consumables1 manufacturer
- Parent category : Instruments for endoral radiology50 manufacturers