K160774 is an FDA 510(k) clearance for the IonoStar Plus. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on August 3, 2016, 135 days after receiving the submission on March 21, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K160774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2016 |
| Decision Date | August 03, 2016 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |