K253798
- 510(k) number
- K253798
- Device name
- UltraPrint-Dental Hard Splint UV
- Applicant
- Guangzhou Heygears IMC., Inc. CN
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2026-03-02
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253798.pdf
Official FDA record: K253798
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.