The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Scanora 3d.
| Device ID | K110839 |
| 510k Number | K110839 |
| Device Name: | SCANORA 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI Fin-04300 |
| Contact | Matti Tulikoura |
| Correspondent | Matti Tulikoura SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI Fin-04300 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-25 |
| Decision Date | 2011-06-30 |
| Summary: | summary |