K140074 is an FDA 510(k) clearance for the HYGEDENT ALGINATE IMPRESSION MATERIAL. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Hygedent, Inc. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on May 21, 2014, 128 days after receiving the submission on January 13, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K140074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2014 |
| Decision Date | May 21, 2014 |
| Days to Decision | 128 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 |