K183337 is an FDA 510(k) clearance for the LuxaCrown, Shade A1, A2, A3, A3.5. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH (Hamburg, DE). The FDA issued a Cleared decision on May 29, 2019, 177 days after receiving the submission on December 3, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K183337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2018 |
| Decision Date | May 29, 2019 |
| Days to Decision | 177 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 |