The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Sirona Dental Cad/cam System.
| Device ID | K111421 |
| 510k Number | K111421 |
| Device Name: | SIRONA DENTAL CAD/CAM SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-20 |
| Decision Date | 2012-02-17 |
| Summary: | summary |