K253953
- 510(k) number
- K253953
- Device name
- IPS e.max Zirconia
- Applicant
- Ivoclar Vivadent, Inc. NY · US
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2026-03-10
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253953.pdf
Official FDA record: K253953
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.