K241316
- 510(k) number
- K241316
- Device name
- Zirconia Block
- Applicant
- Hunan Hualian Special Ceramics Co., Ltd. CN
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-07-09
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241316.pdf
Official FDA record: K241316
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.