The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond Universal.
| Device ID | K130486 |
| 510k Number | K130486 |
| Device Name: | FUTURABOND UNIVERSAL |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | T. Gerkensmeier |
| Correspondent | T. Gerkensmeier VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22127801 | K130486 | 000 |
| E22127501 | K130486 | 000 |
| E22115761 | K130486 | 000 |
| E22115721 | K130486 | 000 |
| E22115711 | K130486 | 000 |
| E221610810 | K130486 | 000 |