Cleared Traditional

CLEARFIL Universal Bond Quick 2

K231039 · Kuraray Noritake Dental, Inc. · Dental
Dec 2023
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K231039 is an FDA 510(k) clearance for the CLEARFIL Universal Bond Quick 2, 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 December 13, 2023, 245 days after receiving the submission on April 12, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K231039 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2023
Decision Date December 13, 2023
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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