The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Amaris/amaris Flow.
| Device ID | K071386 |
| 510k Number | K071386 |
| Device Name: | AMARIS/AMARIS FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfred Thomas Plaumann |
| Correspondent | Manfred Thomas Plaumann 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 | 2007-05-18 |
| Decision Date | 2007-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22119711 | K071386 | 000 |
| E22119461 | K071386 | 000 |
| E22119451 | K071386 | 000 |
| E22119421 | K071386 | 000 |
| E22119411 | K071386 | 000 |
| E22119401 | K071386 | 000 |
| E22119381 | K071386 | 000 |
| E22119371 | K071386 | 000 |
| E22119361 | K071386 | 000 |
| E22119351 | K071386 | 000 |
| E22119341 | K071386 | 000 |
| E22119331 | K071386 | 000 |
| E22119491 | K071386 | 000 |
| E22119501 | K071386 | 000 |
| E22119701 | K071386 | 000 |
| E22119671 | K071386 | 000 |
| E22119621 | K071386 | 000 |
| E22119611 | K071386 | 000 |
| E22119601 | K071386 | 000 |
| E22119581 | K071386 | 000 |
| E22119571 | K071386 | 000 |
| E22119561 | K071386 | 000 |
| E22119551 | K071386 | 000 |
| E22119541 | K071386 | 000 |
| E22119531 | K071386 | 000 |
| E22119301 | K071386 | 000 |