The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Futurabond M/futurabond M Single Dose.
| Device ID | K082753 |
| 510k Number | K082753 |
| Device Name: | FUTURABOND M/FUTURABOND M SINGLE DOSE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfred Thomas Plaumann |
| Correspondent | Manfred Thomas Plaumann 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 | 2008-09-19 |
| Decision Date | 2008-11-24 |
| Summary: | summary |