The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Meron Plus Qm.
| Device ID | K180386 |
| 510k Number | K180386 |
| Device Name: | Meron Plus QM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22117281 | K180386 | 000 |
| E22117271 | K180386 | 000 |