GALILEOS
System, X-ray, Extraoral Source, Digital
SIRONA DENTAL SYSTEMS GMBH
The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Galileos.
Pre-market Notification Details
| Device ID | K060892 |
| 510k Number | K060892 |
| Device Name: | GALILEOS |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-04-14 |
| Summary: | summary |
Trademark Results [GALILEOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALILEOS 79030514 not registered Dead/Abandoned |
Sirona Dental Systems GmbH 2006-06-20 |
 GALILEOS 79030513 not registered Dead/Abandoned |
Sirona Dental Systems GmbH 2006-06-20 |
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