K251252
- 510(k) number
- K251252
- Device name
- NOBILCAM IMPAK Disc
- Applicant
- Shandong Huge Dental Material Corporation CN
- Product code
- MQC — Mouthguard, Prescription
- Decision date
- 2025-08-01
- Date received
- 2025-04-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251252.pdf
Official FDA record: K251252
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.