K261261
- 510(k) number
- K261261
- Device name
- Dura-Arch
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd. CN
- Product code
- EBG — Crown And Bridge, Temporary, Resin
- Decision date
- 2026-04-17
- Date received
- 2026-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261261.pdf
Official FDA record: K261261
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.