The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Meron Plus.
| Device ID | K063554 |
| 510k Number | K063554 |
| Device Name: | MERON PLUS |
| Classification | Cement, Dental |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Michael Sus |
| Correspondent | Michael Sus VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-27 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22117371 | K063554 | 000 |
| E22117361 | K063554 | 000 |
| E22117331 | K063554 | 000 |
| E22117321 | K063554 | 000 |
| E22117311 | K063554 | 000 |