510(k) K253798 ยท MQC Mouthguard, Prescription
UltraPrint-Dental Hard Splint UV
| Applicant | Guangzhou Heygears IMC., Inc., Guangzhou, CN |
| Decision | Substantially Equivalent, Mar 2, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253798
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.