Cleared Traditional

CERABIEN MiLai

K250673 · Kuraray Noritake Dental, Inc. · Dental
May 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K250673 is an FDA 510(k) clearance for the CERABIEN MiLai, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Kuraray Noritake Dental, Inc. (Tokyo, JP). The FDA issued a Cleared decision on May 29, 2025, 84 days after receiving the submission on March 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K250673 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2025
Decision Date May 29, 2025
Days to Decision 84 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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