The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Galileos Family.
| Device ID | K123070 |
| 510k Number | K123070 |
| Device Name: | GALILEOS FAMILY |
| Classification | X-ray, Tomography, Computed, Dental |
| 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 | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E27662343922 | K123070 | 000 |
| E27659682632 | K123070 | 000 |