K253501 is an FDA 510(k) clearance for the Hydro Print Premium Fast Set - 454g (1lb) (052037). This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Vigodent Ind?stria E Comercio Ltda (Rio De Janeiro, BR). The FDA issued a Cleared decision on October 31, 2025, 1 day after receiving the submission on October 30, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K253501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2025 |
| Decision Date | October 31, 2025 |
| Days to Decision | 1 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 |