Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Instruments for endoral radiology
EMDN code Z110304
Manufacturers registered in Europe (EUDAMED) 50
- 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) 238
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. | – | SCHICK33 CDR XIOS XG SUPREME XIOS FONA CDR AimRight Holder | registered |
| 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 | K122643 (2013) |
| Dentsply Intl. Present in Europe in other categories | United States | digit Power® Dispenser SmartLite® Pro RINN® Schick Xios XG Supreme Universal | K160232 (2016) |
| Directa AB | Sweden | TrollByte TrollBag Directa Cheek Retractor Camera Sleeve | registered |
| PLASDENT CORPORATION | United States | Plasdent | K201604 (2020) |
| 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 |
| Carestream Health, Inc. Present in Europe in other categories | United States | RVG 6100 RVG 6200 RVG 5100 RVG 6500 RVG 5200 RVG CONNECT | K111649 (2011) |
| Premium Plus International Limited | China | Premium Plus PEARSON SOLEIL | K163447 (2017) |
| Premium Plus (Dongguan) Limited | China | Premium Plus | K220662 (2022) |
| CEFLA SOCIETA' COOPERATIVA | – | myray NewTom Castellini Anthos Stern Weber | registered |
| DuPhaMed B.V. | Netherlands | Cefla DenBite Care Stream Dental Flow Dental | registered |
| JMU DENTAL, INC | – | JMU | registered |
| TIDI PRODUCTS, LLC | United States | TIDISHIELD Patterson Dental, X-Ray Sensor Sheath Sirona TIDI GEM Henry Schein | K132953 (2014) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein Carina Henry Schein Essentials Acclean | K041580 (2004) |
| Gendex Corp. | United States | Gendex eXpert DC™ intraoral x-ray system Gendex GXS-700™ intraoral sensor KaVo GXS-700™ intraoral sensor KaVo GXS-700 Sensor Size 2 KaVo GXS-700 Sensor Size 1 | K935046 (1994) |
| OWANDY RADIOLOGY | – | Owandy-RX DC Owandy-RX PRO Owandy Radiology I-MAX I-MAX 3D | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Visionary by 3D Dental Essentials by 3D Dental Luminary by 3D Dental | registered |
| TAKARA BELMONT CORP. Present in Europe in other categories | United States | PHOT-X IIs Model 505 BELRAY II PHOT-X II, MODEL 303 BELMAX CM BELCYPHER-N BELCYPHER PRO | K163175 (2017) |
| Dental Health Products Inc | – | Health-Tec/DHP PSP Barrier Envelopes Health-Tec/DHP Bite Wing Tabs Health-Tec/DHP Disposable Dappen Dishes Health-Tec/DHP Barrier Products Health-Tec Barrier Film Health-Tec/DHP Headrest Covers | registered |
| Dentsply Professional | – | Disposa-Shield® Sani-Tip® DELTON® Nupro MIDWEST® Sani-Shield® | registered |
| CARGUS INTERNATIONAL, INC | – | MARK3 | registered |
| Ray Co., Ltd. Present in Europe in other categories | South Korea | RIOScan RAYSCAN α-Expert RAYSCAN α RAYSCAN RAYSCAN α-Expert, RAYSCAN α-P | K232325 (2024) |
| Air Techniques, Inc. Present in Europe in other categories | United States | Provecta S-Pan Bite Block Covers ScanX Duo Touch ScanX Ortho ScanX Swift Digital Imaging System VistaScan Ultra View ScanX Classic for Intraoral & Extraoral Imaging | K191623 (2019) |
| Techno-Aide, Inc. | United States | Techno-Aide | registered |
| BLUO ELECTRONICS SRL | – | PantOs 16 xp IntraOs DG PantOs DG xp PantOs 16 xp Ceph IntraOs 70 FONA XDC | registered |
| Ismile Dental Products, Inc. | – | iSmile | registered |
| Steri-Shield Products, Inc. | United States | Steri-Shield | registered |
| Beyes Dental Canada Inc Present in Europe in other categories | United States | DURAY Beyes | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| BENCO DENTAL SUPPLY CO. | – | BENCO SOLEIL | registered |
| MAXILL, INC. | United States | PHOSPHOR PLATE BARRIER ENVELOPES POLYALL CURING LIGHT SLEEVE | registered |
| Peter Brasseler Holdings, LLC | United States | Brasseler USA | registered |
| AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. | – | Patient Armor Barriers Amtouch Barrier Envelopes | 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) |
| Denterprise International, Inc. | United States | Xray2Go Smil-O-Ray MOBILE-X Xray2Go Mini InstaRay Uni-Ray HD | K231202 (2023) |
| Guilin Woodpecker Medical Instrument Co., Ltd. Present in Europe in other categories | China | WOODPECKER DTE DBA | K251438 (2025) |
| Young Innovations, Inc. | United States | Defend Panoramic Young Infinity | registered |
| SCOTT'S DENTAL SUPPLY L.L.C. | – | X-RAY MOUNTS QUICK TEAR (1000/ROLL) SCOTT'S X-RAY SLEEVES 15" x 26" SMALL (250/bx) SCOTT'S HIGHSPEED HP SLEEVE 1" x 8" 500/bx SCOTT'S HEADREST CVR STD 9.5" X 11" (250) SCOTT'S FULL CHAIR COVER 29" X 80" (125/bx) SCOTT'S SYRINGE SLEEVE 2.5"x10" (500) BLUE | registered |
| ImageWorks | – | INTRASKAN DC EVA SELECT EVA SELECT DIRECT EVASOFT | registered |
| Minitube AB | Sweden | OptiClear Sleeves MIXPAC Protective Sleeve VALO™ Barrier Sleeves C20 Intraoral Protective Sheaths OdneClean | K211026 (2021) |
| DENTAMERICA, INC. | United States | APIXIA DIGIREX APIXIA DIGIREX | K060640 (2006) |
| DEXIS LLC | United States | DEXIS Platinum™ intraoral sensor | K090458 (2009) |
| The Atlanta Dental Supply Company | – | Advance Dental Products | registered |
| The Yoshida Dental Mfg. Co., Ltd. Present in Europe in other categories | Japan | Panoura X-ERA ImageWorks Panoura | K182198 (2019) |
| Maquira Industria de Produtos Odontologicos S/A | Brazil | Maquira Cartridge (box) containing one pot with Digital Sensor Cone Positioner | registered |
| PRACTICON, INC. | United States | QUIKsheath Barriers T-Bar Light Handle QUIKsheath Barriers Large Digital X-Ray Sensor PRACTIfilm Barrier Cling Sheets Blue PRACTIfilm Barrier Cling Sheets Clear QUIKsheath Barriers Air-Water Syringe QUIKsheath Barriers Small Digital X-ray Sensor | registered |
| CYBER MEDICAL IMAGING, INC. | United States | XDR XDR CLARITY | registered |
| XZEAL TECHNOLOGIES, INC. | – | XZeal Z70 Wall VET XZeal Z70 Wall XZeal Z70 Mobile VET XZeal Z70 Mobile | registered |
| 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) |
| ICP, INC. | United States | Dental City | registered |
| NICAL SPA | Italy | Nical Smart Micro | K143703 (2015) |
| YOUNG PS ACQUISITION, LLC | – | Panoramic Corporation Panoramic Corporation - Envision C1 Panoramic Corporation - Envision P | registered |
| Dental Basics Inc. | – | Dental Basics | registered |
| Dukal LLC | United States | Unipack Dukal | registered |
| 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) |
| SAFCO DENTAL SUPPLY CO. | United States | Safco SafeWrap Chair Sleeves Safco SafeWrap Curing Light Sleeves Safco Safewrap syringe Safco SafeWrap Basics Syringe Sleeves Safco SafeWrap Tray Sleeves | registered |
| PICOPACK Inc. | South Korea | WeRay WeSensor | K241963 (2024) |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Sleeve-It AeroPro Barriers | registered |
| REMEDI CO.,LTD. Present in Europe in other categories | South Korea | REMEX T100 MobileX Portable X-Ray System REMEX GR100 Intraoral X-ray sensor | K240759 (2024) |
| YOUNG DENTAL MANUFACTURING I, LLC | – | Denticator Narrow Scaler Sleeve | registered |
| Athlos Oy | Finland | DC-Air™ Holder Pack DC-Air™ Intraoral Sensor DC-Air™ Docking Station | K211688 (2021) |
| BURKHART DENTAL SUPPLY CO., THE | – | Burkhart Chair Sleeve Full 29" x 80" (125) Burkhart Chair Cover Plastic 27" x 24" (225) Burkhart Tray Sleeve Size F 11-1/2 x 10-1/2 (500) Burkhart Tray Sleeve A 11 5/8 X 14 1/2 (500) | registered |
| Dental Savings Club Inc | Canada | MISTERXRAY #0 MISTERXRAY #1,5 MISTER X RAY MISTERXRAY #2 | registered |
| Hdx Will Corp. Present in Europe in other categories | South Korea | STAR-X Xcam DENTIOIII series | K192700 (2019) |
| IVOCLAR VIVADENT AKTIENGESELLSCHAFT | – | BLUEPHASE SLEEVES VivaPen Sleeves | registered |
| Suni Medical Imaging, Inc. | United States | SuniIQ SuniRay2 | K162585 (2016) |
| ULTRADENT PRODUCTS, INC. Present in Europe in other categories | United States | VALO VALO GRAND Ultrapro TX Cordless | registered |
| AMD Medicom Inc | Canada | Elements by Hedy Barrier Envelopes | registered |
| 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 |
| PURELIFE, LLC | – | PureLife+ CSR Wrap | registered |
| TOP QUALITY MANUFACTURING, INC. | – | Top Quality Manufacturing Barrier Film Top Quality Manufacturing Half Chair Sleeves | registered |
| CAO Group, Inc. Present in Europe in other categories | United States | Acuity Direct X-Ray Photon Detection | registered |
| 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) |
| Edlen Imaging, LLC | United States | EDLENi Dental Sensor - Size 1 EDLENi Dental Sensor - Size 2 | K150823 (2015) |
| Flight Dental Systems | – | Flight Dental Systems | registered |
| MASTERLINK LLC | United States | Apex | K163282 (2017) |
| POINTIMPLANT Co., Ltd. Present in Europe in other categories | South Korea | Dental Digital X-ray Imaging Device | registered |
| Radiotecnología Industrial, S.A. de C.V. | Mexico | BI Image-X | K160458 (2016) |
| Rolence Enterprise Co. , Ltd. Present in Europe in other categories | Taiwan | Rolence | K202369 (2021) |
| SODIUM SYSTEMS LLC | United States | Aurora | K181636 (2018) |
| SOTA PRECISION OPTICS, INC. | United States | Clio Prime | registered |
| TEMREX CORPORATION | United States | TEMREX BITEWING LOOPS TEMREX BITE WING TABS | registered |
| ZINNOVI INC. | United States | A2Z Imaging | K241649 (2024) |
| B. Ali Impex | Pakistan | ECCO | registered |
| Cleartooth Electronics, Inc. | United States | Cleartooth Digital X-Ray | K033147 (2003) |
| Coramex, S.A. | United States | Corix 70 | K031802 (2003) |
| Cruxell Corp. Present in Europe in other categories | South Korea | CRUXCAN | K211317 (2021) |
| DRTECH Corporation Present in Europe in other categories | South Korea | XERO-alpha | K242591 (2024) |
| Digiray Corp. Present in Europe in other categories | South Korea | FireCR Dental | registered |
| FKA DISTRIBUTING CO., LLC | – | HOMEDICS | registered |
| HU-FRIEDY MFG. CO., LLC | United States | Hu-Friedy | registered |
| Jazz Imaging | United States | Solo | K163224 (2017) |
| Lucas Lifecare, LLC | United States | LifeRay | K241305 (2024) |
| Osstem Implant Co., Ltd._Gasan Branch | – | Osstem | registered |
| Poskom Co., Ltd. Present in Europe in other categories | South Korea | POSKOM Co., Ltd. | registered |
| R.G. ENTERPRISES (U.S.A.), INC. | United States | Geratherm Thermometer Sheaths | registered |
| Radmedix, LLC | United States | Acuity DX+ | registered |
| Sota Cloud Corp. | United States | SOTA Cloud Smart Sensor | K251793 (2026) |
| TULSA DENTAL PRODUCTS LLC | United States | X-Smart | registered |
The 100 most active manufacturers are shown, out of 238.
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