Cleared Traditional

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

K111975 · Kuraray Medical, Inc. · Dental
Oct 2011
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K111975 is an FDA 510(k) clearance for the CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Kuraray Medical, Inc. (Chiyoda-Ku, Tokyo, JP). The FDA issued a Cleared decision on October 14, 2011, 94 days after receiving the submission on July 12, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K111975 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2011
Decision Date October 14, 2011
Days to Decision 94 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