Cleared Traditional

Admira Fusion Flow

K153177 · Voco GmbH · Dental
Jun 2016
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K153177 is an FDA 510(k) clearance for the Admira Fusion Flow, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on June 30, 2016, 240 days after receiving the submission on November 3, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153177 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2015
Decision Date June 30, 2016
Days to Decision 240 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690