The following data is part of a premarket notification filed by Orion Corporation Soredex with the FDA for Oralix Pan Dc Iii Ceph Or Panoramic Mode Only.
| Device ID | K880982 |
| 510k Number | K880982 |
| Device Name: | ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY |
| Classification | System, X-ray, Stationary |
| Applicant | ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510 |
| Contact | Ensio Koskennurmi |
| Correspondent | Ensio Koskennurmi ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-06-06 |