Cleared Traditional

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

K161042 · Kuraray Noritake Dental, Inc. · Dental
Oct 2016
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K161042 is an FDA 510(k) clearance for the CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on October 25, 2016, 195 days after receiving the submission on April 13, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K161042 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2016
Decision Date October 25, 2016
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200