The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Orthophos Xg 3d / Ceph.
| Device ID | K103711 |
| 510k Number | K103711 |
| Device Name: | ORTHOPHOS XG 3D / CEPH |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE 64625 |
| Contact | Fritz Kolle |
| Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE 64625 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2011-03-22 |
| Summary: | summary |