K254112 is an FDA 510(k) clearance for the Dia-X Sil Bite. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by DiaDent Group International (Cheongju-Si, KR). The FDA issued a Cleared decision on March 19, 2026, 90 days after receiving the submission on December 19, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K254112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2025 |
| Decision Date | March 19, 2026 |
| Days to Decision | 90 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 |