Cleared Traditional

CERABIEN ZR

K170834 · Kuraray Noritake Dental, Inc. · Dental
Oct 2017
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K170834 is an FDA 510(k) clearance for the CERABIEN ZR, 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 October 17, 2017, 211 days after receiving the submission on March 20, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K170834 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2017
Decision Date October 17, 2017
Days to Decision 211 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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