K253798 is an FDA 510(k) clearance for the UltraPrint-Dental Hard Splint UV. This device is classified as a Mouthguard, Prescription.
Submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on March 2, 2026, 94 days after receiving the submission on November 28, 2025.
This device falls under the Dental FDA review panel.
| 510(k) Number | K253798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2025 |
| Decision Date | March 02, 2026 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC — Mouthguard, Prescription |
| Device Class | — |