Cleared Traditional

CERABIEN MiLai

K213147 · Kuraray Noritake Dental, Inc. · Dental
Mar 2022
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K213147 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. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on March 28, 2022, 182 days after receiving the submission on September 27, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K213147 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2021
Decision Date March 28, 2022
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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