The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Structur 3.
| Device ID | K120779 |
| 510k Number | K120779 |
| Device Name: | STRUCTUR 3 |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22125181 | K120779 | 000 |
| E22125041 | K120779 | 000 |
| E22125051 | K120779 | 000 |
| E22125061 | K120779 | 000 |
| E22125071 | K120779 | 000 |
| E22125081 | K120779 | 000 |
| E22125091 | K120779 | 000 |
| E22125101 | K120779 | 000 |
| E22125121 | K120779 | 000 |
| E22125131 | K120779 | 000 |
| E22125151 | K120779 | 000 |
| E22125161 | K120779 | 000 |
| E22125171 | K120779 | 000 |
| E22125031 | K120779 | 000 |