The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio So Heavy Flow.
| Device ID | K102354 |
| 510k Number | K102354 |
| Device Name: | GRANDIO SO HEAVY 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 | 2010-08-19 |
| Decision Date | 2010-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22127201 | K102354 | 000 |
| E22126921 | K102354 | 000 |
| E22126911 | K102354 | 000 |
| E22126901 | K102354 | 000 |
| E22126891 | K102354 | 000 |
| E22126881 | K102354 | 000 |
| E22126871 | K102354 | 000 |
| E22126861 | K102354 | 000 |
| E22126851 | K102354 | 000 |
| E22126841 | K102354 | 000 |
| E22126931 | K102354 | 000 |
| E22126941 | K102354 | 000 |
| E22127121 | K102354 | 000 |
| E22127081 | K102354 | 000 |
| E22127071 | K102354 | 000 |
| E22127061 | K102354 | 000 |
| E22127051 | K102354 | 000 |
| E22127041 | K102354 | 000 |
| E22126991 | K102354 | 000 |
| E22126961 | K102354 | 000 |
| E22126951 | K102354 | 000 |
| E22126801 | K102354 | 000 |