Product code OAS
- Device name
- X-Ray, Tomography, Computed, Dental
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1750
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253935 | medXion NEXUS | medXion Technologies, Inc. | 2026-05-15 |
| K260462 | RCT800 | Ray Co., Ltd. | 2026-04-09 |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | 2026-03-31 |
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026-03-10 |
| K253959 | Primevision 3D | Dentsply Sirona | 2026-02-05 |
| K251798 | RCT700 | Ray Co., Ltd. | 2025-11-25 |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025-11-13 |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025-10-08 |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025-04-17 |
| K243903 | RCT600 | Ray Co., Ltd. | 2025-03-12 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025-02-21 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025-02-14 |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 |
| K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | Palodex Group OY | 2024-09-12 |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024-09-06 |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-01-09 |
| K230985 | Planmeca Viso | Planmeca Oy | 2023-12-28 |
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023-12-14 |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | 2023-09-14 |
| K232166 | PreXion3D Expedition | Prexion Corporation | 2023-09-08 |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2023-08-31 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | 2023-07-19 |
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023-07-10 |
| K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023-06-09 |
| K230753 | RCT800 | Ray Co., Ltd. | 2023-04-11 |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023-04-07 |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2023-01-17 |
| K222150 | PreXion3D Expedition | Prexion Corporation | 2023-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033837936411 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 08033837934981 | myray | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 08033837935001 | myray | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 08033837936091 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 08033837936176 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 08033837932994 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2022-06-01 |
| 08033837932888 | myray | CEFLA SOCIETA' COOPERATIVA | 2020-05-04 |
| 08033837932895 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2020-05-04 |
| 08033837932901 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2020-05-04 |
| 08033837931881 | myray | CEFLA SOCIETA' COOPERATIVA | 2019-05-17 |
| 08033837931898 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2019-05-17 |
| 08033837931904 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2019-05-17 |
| 08033837931379 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2019-04-01 |
| 08057737128318 | X-MIND prime | VILLA SISTEMI MEDICALI SPA | 2019-03-08 |
| 08057737127915 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2018-11-22 |
| 08800016400533 | PaX-i3D Green | VATECH CO., LTD. | 2018-02-13 |
| 08033837931461 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-02-24 |
| 08033837931454 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-02-24 |
| 08033837930716 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |
| 08033837930440 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |
| 08800016400038 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400045 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400052 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400113 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400120 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400144 | PaX-i3D Green | VATECH CO., LTD. | 2016-09-16 |
| 08800016400182 | PaX-i3D | VATECH CO., LTD. | 2016-09-16 |
| 08800016400199 | PaX-i3D | VATECH CO., LTD. | 2016-09-16 |
| 08800016400229 | PaX-i3D | VATECH CO., LTD. | 2016-09-16 |
| 08800016400236 | PaX-i3D | VATECH CO., LTD. | 2016-09-16 |