The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Admira Fusion X-tra.
| Device ID | K151956 |
| 510k Number | K151956 |
| Device Name: | Admira Fusion X-tra |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472 |
| Contact | M Th Plaumann |
| Correspondent | T Gerkensmeier VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-15 |
| Decision Date | 2015-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22128151 | K151956 | 000 |
| E22128141 | K151956 | 000 |
| E22128111 | K151956 | 000 |
| E22128101 | K151956 | 000 |
| E22128081 | K151956 | 000 |