Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Instruments for extraoral dental radiology
EMDN code Z110303
Manufacturers registered in Europe (EUDAMED) 15
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Ray FDA EU representative : Emergo Europe B.V. (Netherlands) | South Korea |
|
IIb 93/42 | Website EUDAMED record Report an error |
| Genoray FDA EU representative : Obelis s.a. (Belgium) | South Korea |
2 others |
IIb MDR, 93/42 | EUDAMED record Report an error |
| Dentium FDA EU representative : Emergo Europe B.V. (Netherlands) | South Korea | IIb MDR, 93/42 | EUDAMED record Report an error | |
| Pointimplant FDA EU representative : Advena Limited (Malta) | South Korea | IIb 93/42 | Website info_uvimplant@pointnix.com EUDAMED record Report an error | |
| Carestream Dental FDA EU representative : TROPHY (France) | United States |
|
IIb MDR | EUDAMED record Report an error |
| J. Morita Mfg FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Japan | IIb MDR, 93/42 | Website EUDAMED record Report an error | |
| Largev FDA EU representative : Eunitor GmbH (Germany) | China | IIb MDR | Website EUDAMED record Report an error | |
| Fussen Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Yofomedical FDA EU representative : Eunitor GmbH (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Cefla FDA | Italy | IIb MDR | Website EUDAMED record Report an error | |
| de Götzen FDA | Italy | IIb MDR | Website qualitydegotzen@acteongroup.com EUDAMED record Report an error | |
| Hdx Will FDA EU representative : KTR Europe GmbH (Germany) | South Korea | IIa MDR | Website EUDAMED record Report an error | |
| MegaGen Implant FDA EU representative : MDSS GmbH (Germany) | South Korea |
|
IIb MDR | EUDAMED record Report an error |
| Vatech FDA EU representative : VATECH GLOBAL FRANCE SARL (France) | South Korea | IIb MDR | Website EUDAMED record Report an error | |
| Wh FDA | Italy | IIb MDR | Website office.sterilization@wh.com EUDAMED record Report an error |
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) 113
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 |
|---|---|---|---|
| SIRONA DENTAL, INC. | – | SCHICK ELITE Schick AE XIOS AE SCHICK WIFI XIOS XG WIFI CDR ELITE | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark Intraoral Digital Sensor Midmark OptiMax Digital Sensor System Midmark Extraoral Imaging System (EOIS) Midmark ClearVision Digital Sensor System Midmark Progeny Imaging Software Midmark ClearVision Digital Sensor System with Laptop | K201667 (2020) |
| Carestream Health, Inc. Present in Europe in other categories | United States | CS 7400 CS 8100SC CS 8100 CS 7200 CS 7600 SLOT PANEL CS 7600 | K111649 (2011) |
| Dental Imaging Technologies Corporation Present in Europe in other categories | United States | DEXIS Titanium Sensor Kit DEXIS Ti2 Sensor Kit DEXIS IXS Size 2 Sensor Kit DEXIS IXS Size 1 Sensor Kit DEXIS IXS S1 Kit DEXIS Ti2 Kit - S | K233053 (2023) |
| CEFLA SOCIETA' COOPERATIVA | – | myray NewTom Castellini | registered |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | Intraoral Dental Digital Imaging Sensor EVOLVE SENSOR Dental CT Scanner AXR SXR / Saevo PREXION EVOLVE | K223816 (2023) |
| Sirona Dental Systems GmbH Present in Europe in other categories | United States | ORTHOPHOS SL Orthophos S Sleeve for extraoral X-Ray devices ORTHOPHOS XG Axeos Primevision 3D | K150217 (2015) |
| Gendex Corp. | United States | Gendex GXS-700™ intraoral sensor KaVo GXS-700™ intraoral sensor KaVo GXS-700 Sensor Size 2 KaVo GXS-700 Sensor Size 1 | registered |
| Rayence Co., Ltd. Present in Europe in other categories | South Korea | EzSensor EzSensor Classic HDI-P HDI-S EzSensor HD EzSensor Soft 2.0 | K153060 (2015) |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | Beyes DURAY | registered |
| Palodex Group OY Present in Europe in other categories | Finland | ORTHOPANTOMOGRAPH™ OP 3D ORTHOPANTOMOGRAPH OP 3D Pro ORTHOPANTOMOGRAPH OP 3D Ceph upgrade kit for OP 3D | K241249 (2024) |
| OWANDY RADIOLOGY | – | Owandy Radiology I-MAX I-MAX 3D | registered |
| DÜRR DENTAL SE Present in Europe in other categories | Germany | SensorX Size #1 SensorX Size #2 ScanX Edge ScanX Intraoral View ScanX Classic View ScanX Swift 2.0 | K230095 (2023) |
| BLUO ELECTRONICS SRL | – | FONA ART Plus C PantOs 16 xp StarX PRO-2 StarX-1 FONA ART Plus PantOs DG xp | registered |
| The Yoshida Dental Mfg. Co., Ltd. Present in Europe in other categories | Japan | Panoura X-ERA ImageWorks Panoura PreXion3D PreXion3D Eclipse | K182198 (2019) |
| iRay Group Present in Europe in other categories | China | Digital Intraoral X-ray Imaging System Digital Wireless Intraoral X-Ray Sensor Digital Intraoral X-Ray Sensor | registered |
| Denterprise International, Inc. | United States | InstaRay Uni-Ray HD QuickRay #1 QUICK Ray HD No Logo #2 QuickRay DX Size 2 Quick Ray HD No Logo #1 | K231202 (2023) |
| DEXIS LLC | United States | DEXIS Platinum™ intraoral sensor | K090458 (2009) |
| Trident S.R.L Present in Europe in other categories | Italy | I-View Gold Imagen Gold Dental Sensors Blu Imagen Sensor BOOM size 2 I-View Silver Imagen Sensor BOOM | K222666 (2023) |
| Air Techniques, Inc. Present in Europe in other categories | United States | ScanX Duo Touch ScanX Ortho ScanX Swift Digital Imaging System VistaScan Ultra View ScanX Classic for Intraoral & Extraoral Imaging ScanX Duo | K191623 (2019) |
| ImageWorks | – | EVA SELECT EVA SELECT DIRECT EVASOFT | registered |
| TAKARA BELMONT CORP. Present in Europe in other categories | United States | BELRAY II BELMAX CM BELCYPHER-N BELCYPHER PRO | K163175 (2017) |
| CYBER MEDICAL IMAGING, INC. | United States | XDR XDR CLARITY | registered |
| Guilin Woodpecker Medical Instrument Co., Ltd. Present in Europe in other categories | China | WOODPECKER DTE DBA | K212080 (2021) |
| Dexcowin Co., Ltd. Present in Europe in other categories | South Korea | Cocoon Cocoon Solo DX3000; iRay; iRay D3 ADX6000; iRay A6 ADX4000; iRay D4 Rex 2 | K173046 (2017) |
| NICAL SPA | Italy | Nical Smart Micro | K143703 (2015) |
| Osstem Implant Co., Ltd. Present in Europe in other categories | South Korea | T2 T2 Plus T1-C T1-CS | K233806 (2024) |
| Prexion Corporation | Japan | PreXion3D Expedition PreXion3D Explorer PreXion3D Explorer EX PreXion3D Explorer PRO | K232166 (2023) |
| Dental Savings Club Inc | Canada | MISTERXRAY #0 MISTERXRAY #1,5 MISTER X RAY MISTERXRAY #2 | registered |
| PICOPACK Inc. | South Korea | WeSensor | K230916 (2023) |
| Planmeca Oy Present in Europe in other categories | Finland | Planmeca Viso | K230985 (2023) |
| Sopro Present in Europe in other categories | France | ACTEON | K092329 (2010) |
| Suni Medical Imaging, Inc. | United States | SuniIQ SuniRay2 | K162585 (2016) |
| Athlos Oy | Finland | DC-Air™ Intraoral Sensor DC-Air™ Docking Station | K211688 (2021) |
| BENCO DENTAL SUPPLY CO. | – | BENCO | registered |
| Changzhou Sifary Medical Technology Co., Ltd. Present in Europe in other categories | China | Eighteeth | registered |
| DENTAMERICA, INC. | United States | APIXIA DIGIREX | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA | registered |
| CAO Group, Inc. Present in Europe in other categories | United States | Acuity Direct X-Ray Photon Detection | registered |
| Edlen Imaging, LLC | United States | EDLENi Dental Sensor - Size 1 EDLENi Dental Sensor - Size 2 | K151137 (2016) |
| Flight Dental Systems | – | Flight Dental Systems | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Carina Henry Schein | K041580 (2004) |
| MASTERLINK LLC | United States | Apex | K163282 (2017) |
| REMEDI CO.,LTD. Present in Europe in other categories | South Korea | Intraoral X-ray sensor | K200284 (2020) |
| SODIUM SYSTEMS LLC | United States | Aurora | K181636 (2018) |
| SOTA PRECISION OPTICS, INC. | United States | Clio Prime | registered |
| Shenzhen Xpectvision Technology Co.,Ltd. Present in Europe in other categories | China | XLinearVision | K220277 (2022) |
| XORAN TECHNOLOGIES LLC Present in Europe in other categories | United States | Xoran Workstation | registered |
| YOUNG PS ACQUISITION, LLC | – | Panoramic Corporation - Envision C1 Panoramic Corporation - Envision P | registered |
| ZINNOVI INC. | United States | A2Z Imaging | K241649 (2024) |
| Changzhou Finno Medical Technology Co., Ltd. Present in Europe in other categories | China | Eighteeth | K242805 (2025) |
| Cleartooth Electronics, Inc. | United States | Cleartooth Digital X-Ray | K033147 (2003) |
| Cruxell Corp. Present in Europe in other categories | South Korea | CRUXCAN | K211317 (2021) |
| Digiray Corp. Present in Europe in other categories | South Korea | FireCR Dental | registered |
| FKA DISTRIBUTING CO., LLC | – | HOMEDICS | registered |
| IcRco, Inc. | United States | CLARIS | K120753 (2012) |
| Jazz Imaging | United States | Solo | K163224 (2017) |
| Planmed OY Present in Europe in other categories | Finland | Planmed | K213278 (2022) |
| Rolence Enterprise Co. , Ltd. Present in Europe in other categories | Taiwan | Rolence | K202369 (2021) |
| Sota Cloud Corp. | United States | SOTA Cloud Smart Sensor | K251793 (2026) |
| Yian Medical Technology (Haining) Co., Ltd. | China | Dental Cone-beam Computed Tomography | K251642 (2025) |
| Alliage S/A Industrias Medica Odontológico. | Brazil | – | K230732 (2023) |
| Carestream Healthcare International Company Limited Present in Europe in other categories | China | – | registered |
| Changzhou Boen Zhongding Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K250839 (2026) |
| Cnd Global Technologies, Inc. | United States | – | K190234 (2019) |
| Curvebeam, LLC Present in Europe in other categories | United States | – | registered |
| DENTSPLY SIRONA INC | United States | – | K253959 (2026) |
| DHEF INC. Present in Europe in other categories | Taiwan | – | registered |
| Dentimax, Inc. | United States | – | K251206 (2025) |
| Denttio, Inc. | United States | – | K153144 (2016) |
| Dexcowin Global, Inc. | United States | – | K250687 (2025) |
| Duerr Dental AG Present in Europe in other categories | Germany | – | K170733 (2017) |
| Epica International, Inc. | United States | – | K190856 (2019) |
| Fona S.R.L | Italy | – | K213579 (2022) |
| Fsusen Technology Co., Ltd. | China | – | K192766 (2019) |
| Handpiece Headquarters | United States | – | registered |
| Hefei Dentafilm Medical Equipment Co., Ltd. | China | – | K214091 (2022) |
| Hefei Meyer Optoelectronic Technology, Inc. Present in Europe in other categories | China | – | K261748 (2026) |
| IRAY Imaging LLC | United States | – | registered |
| Imaging Sciences Intl., Inc. Present in Europe in other categories | United States | – | K162085 (2016) |
| Iray Imaging Technology (Haining) Limited | China | – | K230998 (2023) |
| Iray Technology Taicang , Ltd. | China | – | K220422 (2022) |
| J. Morita USA, Inc. | United States | – | K201378 (2021) |
| Jazz Imaging, LLC Dba Jazz Imaging | United States | – | K213637 (2021) |
| Jiangsu Dynamic Medical Technology Co., Ltd. | China | – | K231660 (2023) |
| KASHMIR SURGICAL WORKS | India | – | registered |
| Kavo Dental Technologies, LLC Present in Europe in other categories | United States | – | K172918 (2017) |
| LBN Medical ApS | Denmark | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Ningbo Runyes Medical Instrument Co., Ltd. Present in Europe in other categories | China | – | registered |
| Nobel Biocare Services AG Present in Europe in other categories | Switzerland | – | registered |
| ONVET MEDICAL CANADA INC | Canada | – | registered |
| Orich Medical Equipment (Tianjin) Co., Ltd. | China | – | registered |
| Panoramic Corp. | United States | – | K152489 (2016) |
| Qpix Solutions, Inc. | United States | – | K261663 (2026) |
| Realcloud Imaging Inc. Dba Realcloud Imaging | United States | – | K221955 (2022) |
| Rolence Ent., Inc. | Taiwan | – | registered |
| SMK Imaging LLC | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Satelec - Acteon Group | United States | – | registered |
The 100 most active manufacturers are shown, out of 113.
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