The following data is part of a premarket notification filed by Voco Gmbh with the FDA for N-hybride-composite Lc Flow.
| Device ID | K113444 |
| 510k Number | K113444 |
| Device Name: | N-HYBRIDE-COMPOSITE LC FLOW |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2011-12-21 |