Cleared Special

Provicol QM Aesthetic

K201856 · Voco GmbH · Dental
Aug 2020
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K201856 is an FDA 510(k) clearance for the Provicol QM Aesthetic, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on August 26, 2020, 51 days after receiving the submission on July 6, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K201856 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2020
Decision Date August 26, 2020
Days to Decision 51 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275