IPS e.max Zirconia— 510(k) K253953
Substantially EquivalentIvoclar Vivadent, Inc.
FDA 510(k) clearance K253953 for IPS e.max Zirconia, Substantially Equivalent on 2026-03-10. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.
Summary
Ivoclar Vivadent's IPS e.max Zirconia is filed under EIH, porcelain powder. The record doesn't describe the material beyond its name and that code name.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ivoclar Vivadent filed from Amherst, New York. Review took 90 calendar days (December 10, 2025 to March 10, 2026).
Clearance details
- Applicant
- Ivoclar Vivadent, Inc.
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Amherst, NY, US
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