K250969 is an FDA 510(k) clearance for the JET BITE. 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 June 27, 2025, 88 days after receiving the submission on March 31, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K250969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | June 27, 2025 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |