Cleared Special

CLEARFIL MAJETY POSTERIOR

K100328 · Kuraray Medical, Inc. · Dental
Mar 2010
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K100328 is an FDA 510(k) clearance for the CLEARFIL MAJETY POSTERIOR, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on March 5, 2010, 29 days after receiving the submission on February 4, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K100328 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2010
Decision Date March 05, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

More from Kuraray Medical, Inc.

View all
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120378 · EMA · Mar 2012
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
K120379 · EMA · Mar 2012
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
K111975 · KLE · Oct 2011
CLEARFIL MAJESTY POSTERIOR PLT
K092281 · EBF · Oct 2009
CLEARFIL SA CEMENT
K081583 · EMA · Jul 2008