The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sidexis 4.
| Device ID | K132773 |
| 510k Number | K132773 |
| Device Name: | SIDEXIS 4 |
| Classification | System, Image Processing, Radiological |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-05 |
| Decision Date | 2013-12-11 |
| Summary: | summary |