The following data is part of a premarket notification filed by Voco Gmbh with the FDA for X-tra Fil.
Device ID | K053391 |
510k Number | K053391 |
Device Name: | X-TRA FIL |
Classification | Material, Tooth Shade, Resin |
Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Contact | Michael Sus |
Correspondent | Michael Sus VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-05 |
Decision Date | 2006-02-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
X-TRA FIL 79227102 5563255 Live/Registered |
VOCO GmbH 2018-01-11 |