Not currently registered with FDA under this name
Prexion Corporation
Chiyoda-Ku, Japan. Named as applicant on 9 dental 510(k) clearances between 2016 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92016–2023
- Markets registered in
- 45 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Prexion Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Prexion Corporation | 9 clearances | 2016–2023 | Below |
| Canada | Health Canada | Registration holder | PREXION CORPORATION | 2 | 2022–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PreXion Corporation | 2 | 2023–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | PreXion Corporation | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Prexion Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Sep 2023 | K232166 | PreXion3D Expedition | OAS Dental Computed Tomography X-Ray |
| 12 Jan 2023 | K222150 | PreXion3D Expedition | OAS Dental Computed Tomography X-Ray |
| 22 Jul 2022 | K221525 | PreXion3D Explorer PRO | OAS Dental Computed Tomography X-Ray |
| 23 Feb 2021 | K203784 | PreXion3D Explorer PRO | OAS Dental Computed Tomography X-Ray |
| 9 Apr 2020 | K193329 | PreXion3D Explorer EX | OAS Dental Computed Tomography X-Ray |
| 15 Apr 2019 | K190320 | PreXion3D Explorer | OAS Dental Computed Tomography X-Ray |
| 17 Aug 2018 | K181983 | PreXion 3D Excelsior | OAS Dental Computed Tomography X-Ray |
| 19 Jan 2018 | K173878 | PreXion3D Excelsior | OAS Dental Computed Tomography X-Ray |
| 3 Oct 2016 | K161881 | PreXion3D Excelsior | OAS Dental Computed Tomography X-Ray |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.