K241204
- 510(k) number
- K241204
- Device name
- TopCEM-Veneer Light Cure Veneer Cement
- Applicant
- Rizhao Huge Biomaterials Company, Ltd. CN
- Product code
- EMA — Cement, Dental
- Decision date
- 2024-06-28
- Date received
- 2024-04-30
- 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: K241204.pdf
Official FDA record: K241204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.