The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Admira Fusion X-base.
| Device ID | K170896 |
| 510k Number | K170896 |
| Device Name: | Admira Fusion X-base |
| 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 | 2017-03-27 |
| Decision Date | 2017-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22128361 | K170896 | 000 |
| E2212836 | K170896 | 000 |
| E22128131 | K170896 | 000 |
| E22128121 | K170896 | 000 |