The following data is part of a premarket notification filed by Prexion Corporation with the FDA for Prexion3d Explorer Pro.
| Device ID | K221525 |
| 510k Number | K221525 |
| Device Name: | PreXion3D Explorer PRO |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PreXion Corporation 1-14-1, Kandasuda-cho Chiyoda-ku, JP 101-0041 |
| Contact | Hiroaki Takahashi |
| Correspondent | Hiroaki Takahashi PreXion Corporation 1-14-1, Kandasuda-cho Chiyoda-ku, JP 101-0041 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-26 |
| Decision Date | 2022-07-22 |