K250534
- 510(k) number
- K250534
- Device name
- Biomic Color Opaque
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd. CN
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2025-05-20
- Date received
- 2025-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250534.pdf
Official FDA record: K250534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.