Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsInstruments for extraoral dental radiology
Equipment for extraoral dental radiology
EMDN code Z11030301
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) 40
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 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) |
| Alliage S/A Indústrias Médico Odontológica Present in Europe in other categories | Brazil | Dental CT Scanner AXR SXR / Saevo PREXION EVOLVE | K223816 (2023) |
| Carestream Health, Inc. Present in Europe in other categories | United States | CS 9300 CS 9300C CS 9300 Select CS 9300C Select CS 9000C 3D CS 8100 3D | registered |
| CEFLA SOCIETA' COOPERATIVA | – | NewTom myray Castellini | 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) |
| Midmark Corp. Present in Europe in other categories | United States | Midmark Extraoral Imaging System (EOIS) | K201667 (2020) |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | DURAY | registered |
| Dental Imaging Technologies Corporation Present in Europe in other categories | United States | i-CAT FLX™ imaging system OP 3D Vision | registered |
| DÜRR DENTAL SE Present in Europe in other categories | Germany | ProVecta 3D Prime Ceph ProVecta 3D Prime | K232487 (2023) |
| 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) |
| BLUO ELECTRONICS SRL | – | Stellaris 2D Ceph Stellaris 2D Stellaris 3D Ceph Stellaris 3D | registered |
| Planmeca Oy Present in Europe in other categories | Finland | Planmeca Viso | K230985 (2023) |
| OWANDY RADIOLOGY | – | I-MAX 3D Owandy Radiology | registered |
| The Yoshida Dental Mfg. Co., Ltd. Present in Europe in other categories | Japan | PreXion3D PreXion3D Eclipse | K122199 (2013) |
| XORAN TECHNOLOGIES LLC Present in Europe in other categories | United States | Xoran Workstation | registered |
| Changzhou Finno Medical Technology Co., Ltd. Present in Europe in other categories | China | Eighteeth | K242805 (2025) |
| IcRco, Inc. | United States | CLARIS | K120753 (2012) |
| Planmed OY Present in Europe in other categories | Finland | Planmed | K213278 (2022) |
| Yian Medical Technology (Haining) Co., Ltd. | China | Dental Cone-beam Computed Tomography | K251642 (2025) |
| Changzhou Boen Zhongding Medical Technology Co., Ltd. Present in Europe in other categories | China | – | K250839 (2026) |
| Changzhou Sifary Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Curvebeam, LLC Present in Europe in other categories | United States | – | registered |
| DENTSPLY SIRONA INC | United States | – | K253959 (2026) |
| Edlen Imaging, LLC | United States | – | K151137 (2016) |
| Epica International, Inc. | United States | – | K190856 (2019) |
| Fona S.R.L | Italy | – | K213579 (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) |
| J. Morita USA, Inc. | United States | – | K201378 (2021) |
| LBN Medical ApS | Denmark | – | registered |
| Panoramic Corp. | United States | – | K152489 (2016) |
| Sanicure BV | Netherlands | – | registered |
| Trident S.R.L Present in Europe in other categories | Italy | – | K222666 (2023) |
| Trophy | France | – | K200183 (2020) |
| Turner Medical Inc. | United States | – | registered |
| Villa Sistemi Medicali S.P.A. Present in Europe in other categories | Italy | – | K180601 (2018) |
| XLINE S.r.l. | Italy | – | registered |
| medXion Technologies, Inc. | Japan | – | K253935 (2026) |
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Related categories
- Instruments for extraoral dental radiology - medical device software12 manufacturers
- Instruments for extraoral dental radiology - hardware accessories2 manufacturers
- Instruments for extraoral dental radiology - consumables2 manufacturers
- Instruments for extraoral dental radiology - software accessories1 manufacturer
- Parent category : Instruments for extraoral dental radiology15 manufacturers