K253053
- 510(k) number
- K253053
- Device name
- Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd. CN
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-09-23
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253053.pdf
Official FDA record: K253053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.