Cleared Traditional

Provicol QM Plus

K161630 · Voco GmbH · Dental
Sep 2016
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K161630 is an FDA 510(k) clearance for the Provicol QM Plus, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on September 15, 2016, 94 days after receiving the submission on June 13, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K161630 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2016
Decision Date September 15, 2016
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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