The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Admira Fusion Flow.
| Device ID | K153177 |
| 510k Number | K153177 |
| Device Name: | Admira Fusion Flow |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472 |
| Contact | Manfred Thomas 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 | 2015-11-03 |
| Decision Date | 2016-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22128321 | K153177 | 000 |
| E22128171 | K153177 | 000 |
| E22128181 | K153177 | 000 |
| E22128191 | K153177 | 000 |
| E22128201 | K153177 | 000 |
| E22128211 | K153177 | 000 |
| E22128221 | K153177 | 000 |
| E22128241 | K153177 | 000 |
| E22128251 | K153177 | 000 |
| E22128261 | K153177 | 000 |
| E22128281 | K153177 | 000 |
| E22128291 | K153177 | 000 |
| E22128311 | K153177 | 000 |
| E22128161 | K153177 | 000 |