Cleared Traditional

DYRACT CEM PLUS CEMENT

K041272 · Dentsply Intl. · Dental
Oct 2004
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K041272 is an FDA 510(k) clearance for the DYRACT CEM PLUS CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 18, 2004, 159 days after receiving the submission on May 12, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K041272 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2004
Decision Date October 18, 2004
Days to Decision 159 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