Cleared Traditional

Noritake Super Porcelain EX-3

K193060 · Kuraray Noritake Dental, Inc. · Dental
Jan 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K193060 is an FDA 510(k) clearance for the Noritake Super Porcelain EX-3, 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 January 30, 2020, 90 days after receiving the submission on November 1, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K193060 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2019
Decision Date January 30, 2020
Days to Decision 90 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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