K250497
- 510(k) number
- K250497
- Device name
- Additive Manufacturing (Light Curing) Crown Bridge Resin
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd. CN
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2025-04-30
- Date received
- 2025-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250497.pdf
Official FDA record: K250497
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.