The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Orthopantomograph Op 3d.
| Device ID | K170813 |
| 510k Number | K170813 |
| Device Name: | ORTHOPANTOMOGRAPH OP 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PaloDEx Group Oy Nahkelantie 160 Tuusula, FI 04300 |
| Contact | Terho Turkumaki |
| Correspondent | Terho Turkumaki PaloDEx Group Oy Nahkelantie 160 Tuusula, 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 | 2017-03-17 |
| Decision Date | 2017-04-07 |
| Summary: | summary |