Cleared Abbreviated

TEMPOCEM

K110759 · Dmg USA, Inc. · Dental
Jun 2011
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K110759 is an FDA 510(k) clearance for the TEMPOCEM, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on June 10, 2011, 84 days after receiving the submission on March 18, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K110759 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2011
Decision Date June 10, 2011
Days to Decision 84 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMB — Zinc Oxide Eugenol
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3275