K250946
- 510(k) number
- K250946
- Device name
- Denture Base Resin DT20
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd. CN
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2025-03-31
- Date received
- 2025-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250946.pdf
Official FDA record: K250946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.