The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Orthopantomograph Op300.
| Device ID | K163423 |
| 510k Number | K163423 |
| Device Name: | Orthopantomograph OP300 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PaloDEx Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
| Contact | Eric Schwandt |
| Correspondent | Eric Schwandt PaloDEx Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-08-31 |