K201483 is an FDA 510(k) clearance for the Impression Material. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Zhengzhou Huaer Electro Optics Technology Co., Ltd. (Zhengzhou, CN). The FDA issued a Cleared decision on October 8, 2020, 126 days after receiving the submission on June 4, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K201483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2020 |
| Decision Date | October 08, 2020 |
| Days to Decision | 126 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 |