510(k) K253798
K253798 is an FDA 510(k) premarket notification submitted by Guangzhou Heygears IMC., Inc. for the device "UltraPrint-Dental Hard Splint UV". The FDA issued a decision of Substantially Equivalent on March 2, 2026. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Guangzhou Heygears IMC., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2026
- Date Received
- November 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type