Cleared Traditional

CLEARFIL SA CEMENT

K081583 · Kuraray Medical, Inc. · Dental
Jul 2008
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K081583 is an FDA 510(k) clearance for the CLEARFIL SA CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on July 28, 2008, 53 days after receiving the submission on June 5, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K081583 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2008
Decision Date July 28, 2008
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275

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