Dental CBCT: manufacturers and brands
30 companies make or specify dental CBCT systems among the 39 that list one with FDA, under 146 brand and model names. FDA has issued 136 510(k) clearances in this category, 42 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental CBCT system 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 |
| Megagen Implant Co., Ltd. | South Korea | Maker | R2 STUDIO Q · RCT820 · RCT820-SC | 30 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | T1 C, T1-CS · T2 (T2-C, T2-CS) · T2 Plus (T2-C-P, T2-CS-P) · T2-C. T2-CS | 68 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | R2 Studio Q · RAYPreMiere · RAYQuantum · RAYSCAN ?-Expert3D · +12 | 21 | 2026 |
| VATECH Co., Ltd. | South Korea | Maker | Green X 12 Plus / Green X Plus (Model: PHT-70CHS) · Green X 12 SE (Model : PHT-40CHS) · Green X 21 (Model : PHT-90CHO) | 33 | 2026 |
| Cefla S.C. | Italy | Maker | EOS Compact · hyperion X5 · hyperion X9 pro · NewTom 5G XL · +8 | 15 | 2026 |
| Genoray Co., Ltd. | South Korea | Maker | GT300 · GT300-C · PAPAYA 3D · PAPAYA 3D Plus · +2 | 14 | 2025 |
| Yian Medical Technology (Haining) Co., Ltd. | China | Maker | Dental CBCT X-ray System · OAS - X-ray, tomography, computed, dental | 3 | 2025 |
| PaloDEx Group Oy | Finland | Maker | ORTHOPANTOMOGRAPH OP 3D · Orthopantomograph OP 3D EX · Orthopantomograph OP 3D EX · Orthopantomograph OP 3D LX · +1 | 9 | 2024 |
| Durr Dental SE | Germany | Maker | ProVecta 3D Prime · ProVecta 3D Prime Ceph · ProVecta 3D Prime with VisionX | 6 | 2023 |
| Alliage S/A Industrias Medico Odontologica | Brazil | Maker | DENTAL CT SCANNER AXR · Eagle Edge/Dabi Atlante AXR120 · Eagle Edge/Dabi Atlante AXR90 · Evolve/Prexion AXR120 · +6 | 3 | 2024 |
| Dental Imaging Technologies Corporation | United States | Maker | i-CAT FLX V-Series · i-CAT FLX V10 · i-CAT FLX V17 · i-CAT FLX V8 · +3 | 2 | 2026 |
| Fussen Technology Co., Ltd | China | Maker | Dental Computed Tomography X-ray System · Rubik XSmart | 2 | 2026 |
| Planmeca Oy | Finland | Maker | Planmeca Viso · Planmeca Viso G5 · Planmeca Viso G7 | 25 | 2023 |
| De Götzen S.R.L. | Italy | Maker | X-MIND optima 3D · X-MIND prime 3D · X-MIND trium | 6 | 2023 |
| Hdx Will Corp. | South Korea | Maker | Dental X-ray system · DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) · +1 | 6 | 2021 |
| Trident SRL | Italy | Maker | X-VIEW 3D PAN; X-VIEW 2D PAN | 5 | 2023 |
| Dentium Co.,Ltd(ICT branch) | South Korea | Maker | bright CT · bright MCT · rainbow CT · rainbow MCT | 3 | 2023 |
| Planmed Oy | Finland | Maker | Planmed Verity | 3 | 2022 |
| Hefei Meyer Optoelectronic Technology Inc. | China | Maker | Dental Cone-beam Computed Tomography (mDX-15P Series) | 1 | 2026 |
| Changzhou Finno Medical Technology Co., Ltd. | China | Maker | Dental Cone-beam Computed Tomography (model: FinScan F350) | 1 | 2025 |
| Carestream Dental LLC | United States | Maker | CEPHALOSTAT · CS 8100 3D · CS 8100 3D Access · CS 8100SC 3D · +9 | 11 | 2020 |
| Epica International | United States | Maker | SEE FACTOR CT3 · SeeFactor CT3 | 1 | 2019 |
| Icrco, Inc. | United States | Maker | Claris CBCT · Claris XT | 1 | 2012 |
| Beyes Dental Inc | Canada | Maker | DURAY 2D, DURAY 2D Ceph, DURAY 3D and DURAY 3D Ceph | — | — |
| J. Morita MFG Corp. | Japan | Maker | Veraview FX800 Model X800N · Veraview X800 | — | — |
| XLINE S.r.l. | Italy | Maker | Stellaris 2D · Stellaris 2D Ceph · Stellaris 3D · Stellaris 3D Ceph | — | — |
| CurveBeam | United States | Maker | PedCAT | — | — |
| IRAY Imaging LLC | United States | Maker | — | — | — |
| Turner Medical Inc. | United States | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Panoramic | 23 | 2025 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Foreign exporter | Dental Cone-beam Computed Tomography (model: FinScan F350) | 4 | 2026 |
| Ray America Inc. | United States | Lister | RAYPreMiere · RAYQUANTUM · RAYSCAN ?-Expert 3D · RAYSCAN a+ · +11 | — | — |
| Owandy Radiology SAS | France | Repacker / relabeler | I-MAX 3D | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Xtechdental Inc. | United States | Lister | Dental Computed Tomography X-ray System · Matrix7000 · Matrix7800 · Rubik Series CBCT · +4 | — | — |
| LBN Medical ApS | Denmark | Foreign exporter | XW8000 Workstation | — | — |
| Genoray America Inc. | United States | Repacker / relabeler | PAPAYA 3D Plus | — | — |
| SG Healthcare Co. Ltd | South Korea | Repacker / relabeler | Hasla | — | — |
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 CBCT systems 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 |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS | 2 | 892.1750 | 30 | 136 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Sep 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd | OAS Dental Computed Tomography X-Ray |
| 23 Jul 2026 | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology Inc. | OAS Dental Computed Tomography X-Ray |
| 11 Jun 2026 | K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 4 Jun 2026 | K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 15 May 2026 | K253935 | medXion NEXUS | medXion Technologies, Inc. | OAS Dental Computed Tomography X-Ray |
| 9 Apr 2026 | K260462 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 31 Mar 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 10 Mar 2026 | K252353 | myray ProXIma X6 | Cefla S.C. | OAS Dental Computed Tomography X-Ray |
| 5 Feb 2026 | K253959 | Primevision 3D | Dentsply Sirona, Inc. | OAS Dental Computed Tomography X-Ray |
| 25 Nov 2025 | K251798 | RCT700 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 13 Nov 2025 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd | OAS Dental Computed Tomography X-Ray |
| 8 Oct 2025 | K250060 | GT300; GT300-C | Genoray Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 27 Jun 2025 | K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 17 Apr 2025 | K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 12 Mar 2025 | K243903 | RCT600 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 21 Feb 2025 | K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 14 Feb 2025 | K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 9 Jan 2025 | K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 12 Sep 2024 | K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | PaloDEx Group Oy | OAS Dental Computed Tomography X-Ray |
| 6 Sep 2024 | K233806 | T2 Plus | Osstem Implant Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 25 Apr 2024 | K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 9 Jan 2024 | K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 28 Dec 2023 | K230985 | Planmeca Viso | Planmeca Oy | OAS Dental Computed Tomography X-Ray |
| 14 Dec 2023 | K231181 | bright CT | Dentium Co.,Ltd(ICT branch) | OAS Dental Computed Tomography X-Ray |
| 14 Sep 2023 | K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | OAS Dental Computed Tomography X-Ray |
| 8 Sep 2023 | K232166 | PreXion3D Expedition | Prexion Corporation | OAS Dental Computed Tomography X-Ray |
| 31 Aug 2023 | K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 19 Jul 2023 | K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 10 Jul 2023 | K222666 | X-View 3D Pan/X-View 2D Pan | Trident SRL | OAS Dental Computed Tomography X-Ray |
| 9 Jun 2023 | K230505 | Orthopantomograph OP 3D LX | PaloDEx Group Oy | OAS Dental Computed Tomography X-Ray |
| 11 Apr 2023 | K230753 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 7 Apr 2023 | K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontologica | OAS Dental Computed Tomography X-Ray |
| 17 Jan 2023 | K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS Dental Computed Tomography X-Ray |
| 12 Jan 2023 | K222150 | PreXion3D Expedition | Prexion Corporation | OAS Dental Computed Tomography X-Ray |
| 6 Dec 2022 | K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 22 Jul 2022 | K221525 | PreXion3D Explorer PRO | Prexion Corporation | OAS Dental Computed Tomography X-Ray |
| 19 May 2022 | K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 28 Apr 2022 | K213278 | Planmed Verity | Planmed Oy | OAS Dental Computed Tomography X-Ray |
| 2 Mar 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | OAS Dental Computed Tomography X-Ray |
| 20 Jan 2022 | K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | OAS Dental Computed Tomography X-Ray |