K250393
- 510(k) number
- K250393
- Device name
- ZircaGlow & ZircaGlow HT Zirconia
- Applicant
- United Zirconia EG
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2025-05-12
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250393.pdf
Official FDA record: K250393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.