The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Provicol Qm Aesthetic.
| Device ID | K201856 |
| 510k Number | K201856 |
| Device Name: | Provicol QM Aesthetic |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22111081 | K201856 | 000 |