Cleared Traditional

Meron Plus QM

K180386 · Voco GmbH · Dental
May 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K180386 is an FDA 510(k) clearance for the Meron Plus QM, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on May 8, 2018, 85 days after receiving the submission on February 12, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K180386 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2018
Decision Date May 08, 2018
Days to Decision 85 days
Submission Type Traditional
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