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 |