K251271
- 510(k) number
- K251271
- Device name
- TempFIT Temporary Crown and Bridge Resin
- Applicant
- Rizhao Huge Biomaterials Company, Ltd. CN
- Product code
- EBG — Crown And Bridge, Temporary, Resin
- Decision date
- 2025-06-23
- Date received
- 2025-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251271.pdf
Official FDA record: K251271
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.