The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ionostar Plus.
| Device ID | K160774 |
| 510k Number | K160774 |
| Device Name: | IonoStar Plus |
| 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 | 2016-03-21 |
| Decision Date | 2016-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22125491 | K160774 | 000 |
| E22125481 | K160774 | 000 |
| E22125471 | K160774 | 000 |
| E22125461 | K160774 | 000 |
| E22125451 | K160774 | 000 |
| E22125441 | K160774 | 000 |
| E22125431 | K160774 | 000 |
| E22125401 | K160774 | 000 |