Cleared Traditional

K150703 - CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
(FDA 510(k) Clearance)

K150703 · Kuraray Noritake Dental, Inc. · Dental
Aug 2015
Decision
148d
Days
Class 2
Risk

K150703 is an FDA 510(k) clearance for the CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial), 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 August 13, 2015, 148 days after receiving the submission on March 18, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K150703 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2015
Decision Date August 13, 2015
Days to Decision 148 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