Cleared Special

GrandioSO Light Flow

K200294 · Voco GmbH · Dental
Mar 2020
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K200294 is an FDA 510(k) clearance for the GrandioSO Light 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 March 27, 2020, 51 days after receiving the submission on February 5, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K200294 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2020
Decision Date March 27, 2020
Days to Decision 51 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