The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio Core Dual Cure.
| Device ID | K112447 |
| 510k Number | K112447 |
| Device Name: | GRANDIO CORE DUAL CURE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-25 |
| Decision Date | 2011-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22119121 | K112447 | 000 |
| E22119111 | K112447 | 000 |
| E22119101 | K112447 | 000 |