The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond M+.
Device ID | K141610 |
510k Number | K141610 |
Device Name: | FUTURABOND M+ |
Classification | Agent, Tooth Bonding, Resin |
Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE 27472 |
Contact | T. Gerkensmeier |
Correspondent | T. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE 27472 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-16 |
Decision Date | 2014-08-01 |