Cleared Traditional

CLEARFIL MAJESTY POSTERIOR PLT

K092281 · Kuraray Medical, Inc. · Dental
Oct 2009
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K092281 is an FDA 510(k) clearance for the CLEARFIL MAJESTY POSTERIOR PLT, 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 October 27, 2009, 90 days after receiving the submission on July 29, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K092281 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2009
Decision Date October 27, 2009
Days to Decision 90 days
Submission Type Traditional
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 MAJETY POSTERIOR
K100328 · EBF · Mar 2010
CLEARFIL SA CEMENT
K081583 · EMA · Jul 2008