The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionolux.
| Device ID | K090817 |
| 510k Number | K090817 |
| Device Name: | IONOLUX |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M.th. Plaumann |
| Correspondent | M.th. Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-25 |
| Decision Date | 2009-07-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IONOLUX 79069975 3750094 Live/Registered |
VOCO GmbH 2009-01-26 |