Cleared Traditional

CLEARFIL MAJESTY IC

K182430 · Kuraray Noritake Dental, Inc. · Dental
May 2019
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K182430 is an FDA 510(k) clearance for the CLEARFIL MAJESTY IC, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on May 3, 2019, 239 days after receiving the submission on September 6, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K182430 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2018
Decision Date May 03, 2019
Days to Decision 239 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690