Cleared Traditional

CALIBRA CEMENT

K040906 · Dentsply Intl. · Dental
Jun 2004
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K040906 is an FDA 510(k) clearance for the CALIBRA CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on June 16, 2004, 70 days after receiving the submission on April 7, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K040906 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2004
Decision Date June 16, 2004
Days to Decision 70 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