K170812 is an FDA 510(k) clearance for the HygePLUS Alginate Impression Material. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Hygedent, Inc. (Beijing, CN). The FDA issued a Cleared decision on July 26, 2017, 131 days after receiving the submission on March 17, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K170812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2017 |
| Decision Date | July 26, 2017 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |