510(k) K251252
K251252 is an FDA 510(k) premarket notification submitted by Shandong Huge Dental Material Corporation for the device "NOBILCAM IMPAK Disc". The FDA issued a decision of Substantially Equivalent on August 1, 2025. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Shandong Huge Dental Material Corporation has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2025
- Date Received
- April 23, 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