The following data is part of a premarket notification filed by Voco Gmbh with the FDA for N-hybride-composite Lc.
| Device ID | K113563 |
| 510k Number | K113563 |
| Device Name: | N-HYBRIDE-COMPOSITE LC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | M.th. Plaumann |
| Correspondent | M.th. Plaumann 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620704115610 | K113563 | 000 |
| D66207041147017 | K113563 | 000 |
| D66207041146218 | K113563 | 000 |
| D66207041145419 | K113563 | 000 |
| D6620704114471 | K113563 | 000 |
| D6620704114391 | K113563 | 000 |