Cleared Traditional

K191980 - CLEARFIL MAJESTY ES Flow
(FDA 510(k) Clearance)

K191980 · Kuraray Noritake Dental, Inc. · Dental
Nov 2019
Decision
117d
Days
Class 2
Risk

K191980 is an FDA 510(k) clearance for the CLEARFIL MAJESTY ES Flow, 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 November 18, 2019, 117 days after receiving the submission on July 24, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K191980 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2019
Decision Date November 18, 2019
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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