K201184 is an FDA 510(k) clearance for the Lascod Impression Materials. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Lascod Spa (Sesto Fiorentino, IT). The FDA issued a Cleared decision on May 5, 2020, 4 days after receiving the submission on May 1, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K201184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | May 05, 2020 |
| Days to Decision | 4 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 |