The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Orthoralix Sd2 & S Panoramic Dental X-ray System.
| Device ID | K960028 |
| 510k Number | K960028 |
| Device Name: | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Intraoral |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | Alan P Krema |
| Correspondent | Alan P Krema DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-01 |