Cleared Special

VisCalor

K201307 · Voco GmbH · Dental
Jul 2020
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K201307 is an FDA 510(k) clearance for the VisCalor, 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 8, 2020, 54 days after receiving the submission on May 15, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K201307 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2020
Decision Date July 08, 2020
Days to Decision 54 days
Submission Type Special
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