Cleared Special

VisCalor bulk

K190453 · Voco GmbH · Dental
Apr 2019
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K190453 is an FDA 510(k) clearance for the VisCalor bulk, 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 April 11, 2019, 45 days after receiving the submission on February 25, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K190453 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2019
Decision Date April 11, 2019
Days to Decision 45 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