K242360 is an FDA 510(k) clearance for the Speedex Light Body. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Dent4you AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 15, 2024, 98 days after receiving the submission on August 9, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K242360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2024 |
| Decision Date | November 15, 2024 |
| Days to Decision | 98 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 |