K250063
- 510(k) number
- K250063
- Device name
- ARENA Star, Galaxy Star
- Applicant
- Arum Dentistry Co., Ltd. KR
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2025-07-10
- Date received
- 2025-01-10
- 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: K250063.pdf
Official FDA record: K250063
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.