Cleared Traditional

IPS e.max Zirconia

K253953 · Ivoclar Vivadent, Inc. · Dental
Mar 2026
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K253953 is an FDA 510(k) clearance for the IPS e.max Zirconia, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 10, 2026, 90 days after receiving the submission on December 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K253953 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2025
Decision Date March 10, 2026
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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