K233082
- 510(k) number
- K233082
- Device name
- TopCEM Dual Cure Resin Cement
- Applicant
- Rizhao Huge Biomaterials Company, Ltd. CN
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2023-12-22
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233082.pdf
Official FDA record: K233082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.