K201684 is an FDA 510(k) clearance for the A-Silicone for Bite Registration. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Shandong Huge Dental Material Corporation (Rizhao City, CN). The FDA issued a Cleared decision on September 24, 2020, 94 days after receiving the submission on June 22, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K201684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2020 |
| Decision Date | September 24, 2020 |
| Days to Decision | 94 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 |