K171562 is an FDA 510(k) clearance for the Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on April 13, 2018, 318 days after receiving the submission on May 30, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K171562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2017 |
| Decision Date | April 13, 2018 |
| Days to Decision | 318 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |