K130421 is an FDA 510(k) clearance for the MERON APPLICATION CAPSULES. 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 14, 2013, 175 days after receiving the submission on February 20, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K130421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2013 |
| Decision Date | August 14, 2013 |
| Days to Decision | 175 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 |