PreXion3D Excelsior
X-ray, Tomography, Computed, Dental
PreXion Corporation
The following data is part of a premarket notification filed by Prexion Corporation with the FDA for Prexion3d Excelsior.
Pre-market Notification Details
| Device ID | K161881 |
| 510k Number | K161881 |
| Device Name: | PreXion3D Excelsior |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PreXion Corporation Funai Tokyo Technology Center Building, 1-14-1 Kandasuda-cho Chiyoda-ku, JP 101-0041 |
| Contact | Shumpeita Torii |
| Correspondent | Shumpeita Torii PreXion Corporation Funai Tokyo Technology Center Building, 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 | 2016-07-08 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
Trademark Results [PreXion3D Excelsior]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREXION3D EXCELSIOR 87196223 5278056 Live/Registered |
PREXION CORPORATION 2016-10-07 |
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