Dental X-ray units: manufacturers and brands
74 companies make or specify dental X-ray units among the 105 that list one with FDA, under 390 brand and model names. FDA has issued 440 510(k) clearances in this category, 58 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental X-ray unit manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | N1 · S2 (digital intra-oral X-ray sensor) | 68 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | RAYSCAN ?-OCL · RAYSCAN ?-OCS · RAYSCAN ?-P · RAYSCAN ?-SC · +4 | 21 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Ai Ray · Ai Ray Lite, Ai Ray Pro, Master Ray · Dental X-Ray Device · Digital Intraoral X-Ray Imaging System · +4 | 12 | 2025 |
| VATECH Co., Ltd. | South Korea | Maker | VistaPano S 2 (Model: VistaPano S) · VistaPano S Ceph 2 (Model: VistaPano S Ceph) | 33 | 2026 |
| Cefla S.C. | Italy | Maker | EOS Compact · hyperion X5 · hyperion X9 pro · NewTom DCiS · +14 | 15 | 2026 |
| Genoray Co., Ltd. | South Korea | Maker | GenX-CR · GT300 · GT300-C · PAPAYA · +18 | 14 | 2025 |
| Qpix Solutions, Inc. | United States | Maker | EzSensor HD (IOS-U10IF) · EzSensor HD (IOS-U15IF) · EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF) · EzSensor HD (IOS-U20IF) · +1 | 4 | 2026 |
| Digimed Co., Ltd. | South Korea | Maker | Dhx-70h · DIOX-602 · Hybrid C70 · HYBRID Pro · +7 | 6 | 2023 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | Hand-held Dental X-ray System (HyperLight-M) · HyperLight Portable X-ray Unit · HyperLight Pro Portable X-ray Unit · Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth · +1 | 4 | 2026 |
| Guilin Refine Medical Instrument Co., LTD. | China | Maker | Portable Dental X-ray Device (Model: GT-1) | 3 | 2026 |
| Satelec - Acteon Group | United States | Maker | PSPIX2 · SOPIX · SOPIX 2 · SOPIX INSIDE, SOPIX2 INSIDE · +3 | 18 | 2024 |
| PaloDEx Group Oy | Finland | Maker | FOCUS · DIGORA Optime | 9 | 2024 |
| Handpiece Headquarters | United States | Maker | Carina · GEM | 7 | 2024 |
| Durr Dental SE | Germany | Maker | ScanX Classic View · ScanX Edge · ScanX Intraoral View · ScanX Swift 2 · +4 | 6 | 2023 |
| Alliage S/A Industrias Medico Odontologica | Brazil | Maker | D700 SLIM · EAGLE S · EVOLVE SENSOR · Portable Dental X-Ray · +5 | 3 | 2024 |
| Ningbo Runyes Medical Instrument Co., Ltd. | China | Maker | Diagnostic X-Ray Equipment MobileX R98 · Diagnostic X-Ray Equipment POCT22 · Diagnostic X-Ray Equipment RAY88(P) · Diagnostic X-Ray Equipment RAY98(P) · +3 | 2 | 2026 |
| Dental Imaging Technologies Corporation | United States | Maker | NOMAD Pro 2 · NOMAD Pro 3 · DEXIS IXS Size 1 · DEXIS IXS Size 1 Intraoral Sensor · +4 | 2 | 2026 |
| Fussen Technology Co., Ltd | China | Maker | Digital Intraoral Imaging Plate System | 2 | 2026 |
| Shenzhen Xpectvision Technology Co., Ltd. | China | Maker | XpectVision, Handheld Dental X-ray System, XVbeam2000 · XVD2121 Plus · XVD2530 | 2 | 2024 |
| PICOPACK Inc. | South Korea | Maker | WeRay · MDP · WeSensor | 2 | 2024 |
| iRay Imaging Technology (Haining) Limited | China | Maker | Canis014D07 | 2 | 2023 |
| Planmeca Oy | Finland | Maker | Planmeca ProMax · Planmeca ProMax 3D · Planmeca ProMax 3D Mid · Planmeca ProMax 3D Plus · +3 | 25 | 2023 |
| Midmark Corporation | United States | Maker | Midmark Intraoral Digital Sensor · PROGENY IMAGING SOFTWARE · Preva, Extraoral X-Ray System | 7 | 2025 |
| De Götzen S.R.L. | Italy | Maker | U-SENSE · U-SENSE HD · X-MIND optima · X-MIND optima 3D · +5 | 6 | 2023 |
| Hdx Will Corp. | South Korea | Maker | Star-X; Intraoral X-ray System · Xcam · DENTRA III · DENTIOIII series (DENTIOIII, DENTIOIII-S) | 6 | 2021 |
| Trident SRL | Italy | Maker | Blu · Blu size 2 · BOOM sensor · BOOM sensor size 2 · +11 | 5 | 2023 |
| Rayence Co., Ltd. | South Korea | Maker | — | 5 | 2022 |
| Dentium Co.,Ltd(ICT branch) | South Korea | Maker | IOX1 · IOX2 | 3 | 2023 |
| Remedi Inc. | South Korea | Maker | MobileX T-100 · REMEX-GR100 · REMEX-T100 · T-100 · +1 | 2 | 2024 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700) | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Digital image scanner of dental | 1 | 2023 |
| Shanghai Handy Medical Equipment Co., Ltd. | China | Maker | HDR Sensor · HDR-361 · HDR-461 | 1 | 2022 |
| VSI Co., Ltd. | South Korea | Maker | CLAROX · CLAROX X4 · X4 | 1 | 2022 |
| SOTA Cloud Corporation | United States | Maker | SOTA Cloud Smart Sensor | 1 | 2026 |
| DRTECH Corporation | South Korea | Maker | XERO ? | 1 | 2024 |
| ECOTRON Co., Ltd. | South Korea | Maker | Extraoral source x-ray system DT-703, ProX Go | 1 | 2022 |
| Lucas Lifecare, LLC | United States | Maker | LifeRay Intraoral Handheld X-ray | 1 | 2024 |
| PDX Co., Ltd. | South Korea | Maker | nova | 1 | 2026 |
| Zinnovi Inc. | United States | Maker | DUO1, DUO2 | 1 | 2024 |
| Duerr Dental SE | United States | Maker | ScanX Duo -D1000A, D1000J, D1000T, D1000K · ScanX Duo Touch: J1200 · ScanX Intraoral - F3605, F3600T · ScanX Swift - G8000 · +1 | 14 | 2019 |
| Carestream Dental LLC | United States | Maker | CS 2500P · CS 6200 · CS 7200 · CS 7600 · +23 | 11 | 2020 |
| Prime Dental Manufacturing, Inc. | United States | Maker | — | 9 | 2012 |
| Takara Belmont Corporation | Japan | Maker | PHOT-X II, MODEL 303 · PHOT-X-IIS Model 505 · 097 Bel-Ray II | 7 | 2017 |
| The Yoshida Dental Mfg. Co., Ltd. | Japan | Maker | ImageWorks Panoura · Panoura 18S · Panoura X-ERA · X-era Smart | 6 | 2019 |
| Rolence Ent., Inc. | Taiwan | Maker | Extraoral X-Ray Unit · Intraoral Digital X-Ray Sensor | 5 | 2009 |
| Dexcowin Co., Ltd. | South Korea | Maker | ADX 4000 · Cocoon DX-7017 · Cocoon DX-7020 · COCOON SOLO (DX-7020s) · +5 | 4 | 2017 |
| Skanray Technologies Limited | India | Maker | IMAGESCAN HD · INTRA SKAN DC · INTRASKAN DC · INTRASKAN DC PLUS · +1 | 3 | 2017 |
| Sota Precision Optics, Inc. | United States | Maker | Clio Pedo · Clio Prime | 2 | 2006 |
| Athlos Oy | Finland | Maker | Athlos-1 · Athlos-Air · DC-Air | 1 | 2021 |
| Jazz Imaging | United States | Maker | Minor · Solo | 1 | 2017 |
| Cleartooth Electronics, Inc. | United States | Maker | Cleartooth Digital X-Ray | 1 | 2003 |
| Livermoretech, Inc. | United States | Maker | AIRTOUCH, PORTABLE X-RAY SYSTEM; EZER, PORTABLE X-RAY SYSTEM | 1 | 2019 |
| Nical Spa | Italy | Maker | NICAL SMART MICRO, NSM1001AA,NPR1000AA, NPR1000VE. | 1 | 2015 |
| PointImplant Co Ltd | South Korea | Maker | — | — | — |
| Beyes Dental Inc | Canada | Maker | DURAY ART PLUS Pan/Ceph · Duray Imaging Plate Scanner, Model:DC1 · Duray Intraoral Sensor, Model: DS1; DS2 · DURAY V2 X-Ray Unit | — | — |
| J. Morita MFG Corp. | Japan | Maker | MODEL XDP1 · Veraview FX800 Model X800N · VERAVIEW IC 5 · Veraview X800 · +1 | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | Intraoral Sensor, Size 1, Size 2 | — | — |
| Ads Dental System Inc. | United States | Maker | Dental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700) · PlutoX Digital Intraoral X-ray Imaging System | — | — |
| XLINE S.r.l. | Italy | Maker | FONA XDC · IntraOs 70 · IntraOs DG · PantOs 16 xp · +11 | — | — |
| DIGIRAY Corp. | South Korea | Maker | ClearVision CR · CR500 · Dental CR · EAI DxScan · +7 | — | — |
| O&S Dental Inc | United States | Maker | — | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| iRay Group | China | Maker | CS 6200 Digital Intraoral X-Ray Sensor · Pluto0000X Digital Intraoral X-ray Imaging System · Pluto0001X Digital Intraoral X-ray Imaging System · Pluto0002X Digital Intraoral X-ray Imaging System · +2 | — | — |
| SMK Imaging LLC | United States | Maker | EVA Select · EVA Select Digital Dental Imaging System · EVA SELECT DIRECT · EVA SELECT DIRECT SIZE #1 · +3 | — | — |
| iRay Imaging Technology Taicang Limited | China | Maker | CS 6200 Digital Intraoral X-Ray Sensor · Pluto0002XW · PlutoX Digital Intraoral X-ray Imaging System | — | — |
| Carestream Healthcare International Company Limited | China | Maker | CS 7200; CS 7600; CS 7600 SCAN&GO DEVICE; CS 7600 SLOT PANEL | — | — |
| iRay Korea Limited | South Korea | Maker | Pluto0001X · Pluto0002X | — | — |
| Kashmir Surgical Works | India | Maker | Dental RVG | — | — |
| Poskom Co Ltd | South Korea | Maker | REXTAR X · Xcam | — | — |
| Cyber Medical Imaging, Inc. | United States | Maker | XDR CLARITY | — | — |
| Turner Imaging Systems | United States | Maker | Lumos 3DX | — | — |
| Valkyrie BioScience, Inc | United States | Maker | Lumos 3DX | — | — |
| Zentech Manufacturing, Inc | United States | Maker | — | — | — |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | KaVo NOMAD · DEXIS Titanium, KaVo IXS HD | 94 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Panoramic | 23 | 2025 |
| DentiMax LLC / Arnett | United States | Repacker / relabeler | DentiMax · OpenSensor | 3 | 2025 |
| CAO Group, Inc. | United States | Contract manufacturer | Acuity Direct X-Ray Photon Detection | 13 | 2020 |
| Dentamerica | United States | Repacker / relabeler | APIXIA DIGIREX | 4 | 2010 |
| Vector Research & Development | United States | Repacker / relabeler | MaxRay · MaxRay W68 | 1 | 2002 |
| Masterlink, LLC. | United States | Repacker / relabeler | Apex Dental Sensor 1 · Apex Dental Sensor 2 | 1 | 2017 |
| Apixia, Inc. | United States | Repacker / relabeler | — | 1 | 2012 |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | NOMAD PRO X-RAY SYSTEM · DEXIS SENSOR | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | dental xray · XRay | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Imaging Plate Scanner · X-Ray Sensors | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | xray accessory | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Ai Ray Lite | — | — |
| GoldenDent | United States | Repacker / relabeler | X-Ray | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | X-Vision Portable Handheld X-Ray · XR-3800, XR-3801, XR-3802 | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | xray | — | — |
| Ray America Inc. | United States | Lister | Cocoon Portable Handheld X-Ray System · RAYSCAN ?-Expert · RIOSCAN · RIOSensor+ Intraoral X-ray unit | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Takara Belmont Co · Takara Belmont Corporation · TOYO MEDICAL CO · Toyo Medical Co. | — | — |
| Owandy Radiology SAS | France | Repacker / relabeler | I-MAX · I-MAX 3D · I-MAX Touch · I-MAX Touch 3D · +7 | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Xtechdental Inc. | United States | Lister | Digital Intraoral Imaging Plate System · F200 IMAGE PLATE SYSTEM | — | — |
| LBN Medical ApS | Denmark | Foreign exporter | XW8000 Workstation | — | — |
| Orich Medical Equipment (Tianjin) Co., Ltd. | China | Foreign exporter | Intra Os 70 · Intra OS DG · Panaramic | — | — |
| Genoray America Inc. | United States | Repacker / relabeler | PAPAYA 3D Plus · PAPAYA Plus | — | — |
| RadmediX, LLC | United States | Repacker / relabeler | AcuityDX+ | — | — |
| XRD Dental Equipment | United States | Lister | XRD RAY98(P) | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental X-ray units are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH | 2 | 872.1800 | 53 | 207 |
| Extraoral with Timer X-Ray UnitEHD | 2 | 872.1800 | 40 | 191 |
| Intraoral X-Ray UnitEAP | 2 | 872.1810 | 5 | 42 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Sep 2026 | K261663 | EzSensor HD | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 14 Sep 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 27 May 2026 | K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 20 Mar 2026 | K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | EHD Extraoral with Timer X-Ray Unit |
| 12 Mar 2026 | K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 3 Mar 2026 | K251793 | SOTA Cloud Smart Sensor (1.5) | SOTA Cloud Corporation | MUH Digital Extraoral Source X-Ray System |
| 19 Feb 2026 | K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., LTD. | EHD Extraoral with Timer X-Ray Unit |
| 3 Feb 2026 | K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 10 Nov 2025 | K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 24 Oct 2025 | K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | MUH Digital Extraoral Source X-Ray System |
| 24 Sep 2025 | K251206 | Digital X-Ray DentiMax Pro Imaging System | DentiMax LLC / Arnett | MUH Digital Extraoral Source X-Ray System |
| 4 Sep 2025 | K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 4 Dec 2024 | K242185 | Rextar Pro | Raypia Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 1 Nov 2024 | K242591 | XERO-alpha | DRTECH Corporation | EHD Extraoral with Timer X-Ray Unit |
| 25 Oct 2024 | K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 11 Oct 2024 | K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 30 Jul 2024 | K241963 | WERAY | PICOPACK Inc. | EHD Extraoral with Timer X-Ray Unit |
| 5 Jul 2024 | K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare, LLC | EHD Extraoral with Timer X-Ray Unit |
| 5 Jul 2024 | K241649 | DUO1 and DUO2 | Zinnovi Inc. | MUH Digital Extraoral Source X-Ray System |
| 13 May 2024 | K240759 | REMEX-GR100 | Remedi Inc. | EHD Extraoral with Timer X-Ray Unit |
| 18 Apr 2024 | K232325 | RAYSCAN a-Expert | Ray Co., Ltd, | MUH Digital Extraoral Source X-Ray System |
| 8 Feb 2024 | K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 3 Jan 2024 | K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Medico Odontologica | EHD Extraoral with Timer X-Ray Unit |
| 28 Dec 2023 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | EHD Extraoral with Timer X-Ray Unit |
| 20 Dec 2023 | K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd | MUH Digital Extraoral Source X-Ray System |
| 8 Dec 2023 | K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 28 Nov 2023 | K232012 | N1 | Osstem Implant Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 21 Nov 2023 | K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | MUH Digital Extraoral Source X-Ray System |
| 20 Oct 2023 | K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | MUH Digital Extraoral Source X-Ray System |
| 20 Oct 2023 | K230998 | Digital Wireless Intraoral X-Ray Sensor | iRay Imaging Technology (Haining) Limited | MUH Digital Extraoral Source X-Ray System |
| 10 Oct 2023 | K230916 | WeSensor | PICOPACK Inc. | MUH Digital Extraoral Source X-Ray System |
| 27 Sep 2023 | K232255 | EZSensor XHD | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 13 Sep 2023 | K232158 | GenX-CR | Genoray Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 1 Sep 2023 | K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 13 Jul 2023 | K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 6 Jul 2023 | K223780 | Lumos 3DX | 3Dio | EHD Extraoral with Timer X-Ray Unit |
| 22 Jun 2023 | K231202 | QuickRayPRO | Denterprise International, Inc | MUH Digital Extraoral Source X-Ray System |
| 21 Apr 2023 | K230811 | Digital Intraoral X-Ray Sensor | iRay Imaging Technology (Haining) Limited | MUH Digital Extraoral Source X-Ray System |
| 11 Apr 2023 | K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | MUH Digital Extraoral Source X-Ray System |
| 3 Mar 2023 | K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |