K120779 is an FDA 510(k) clearance for the STRUCTUR 3. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on June 1, 2012, 79 days after receiving the submission on March 14, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K120779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2012 |
| Decision Date | June 01, 2012 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |