Cleared Traditional

PROVISA CEM

K073539 · Cavex Holland BV · Dental
Jan 2008
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K073539 is an FDA 510(k) clearance for the PROVISA CEM, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on January 31, 2008, 45 days after receiving the submission on December 17, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K073539 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2007
Decision Date January 31, 2008
Days to Decision 45 days
Submission Type Traditional
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