K242749
- 510(k) number
- K242749
- Device name
- TopCEM Ceramic Primer Ceramic Coupling Agent
- Applicant
- Rizhao Huge Biomaterials Company, Ltd. CN
- Product code
- KLE — Agent, Tooth Bonding, Resin
- Decision date
- 2024-11-08
- Date received
- 2024-09-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K242749.pdf
Official FDA record: K242749
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.