K251084
- 510(k) number
- K251084
- Device name
- zirkon; structure; LFU shades, stains and glazes
- Applicant
- Estetic Ceram AG LI
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2025-06-05
- Date received
- 2025-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251084.pdf
Official FDA record: K251084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.