K153490 is an FDA 510(k) clearance for the DD medical polymers. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Dental Direkt GmbH (Spenge, DE). The FDA issued a Cleared decision on May 13, 2016, 161 days after receiving the submission on December 4, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K153490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2015 |
| Decision Date | May 13, 2016 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |