IPS e.max Zirconia— 510(k) K253953

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K253953 for IPS e.max Zirconia, Substantially Equivalent on 2026-03-10. Applicant: Ivoclar Vivadent, Inc..

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code EIH
Advisory panel: Dental
Date received: 2025-12-10
Decision date: 2026-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

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