Cleared Traditional

Clip Flow

K153493 · Voco GmbH · Dental
Jul 2016
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K153493 is an FDA 510(k) clearance for the Clip 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 July 29, 2016, 238 days after receiving the submission on December 4, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K153493 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2015
Decision Date July 29, 2016
Days to Decision 238 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