Cleared Traditional

INTEGRITY TEMPORARY CEMENT

K040895 · Dentsply Intl. · Dental
May 2004
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K040895 is an FDA 510(k) clearance for the INTEGRITY TEMPORARY CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on May 21, 2004, 45 days after receiving the submission on April 6, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K040895 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2004
Decision Date May 21, 2004
Days to Decision 45 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