K240912
- 510(k) number
- K240912
- Device name
- Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
- Applicant
- Anhui Miisen Intelligence Technology Co., Ltd. CN
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-05-31
- Date received
- 2024-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K240912.pdf
Official FDA record: K240912
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.