Cleared Traditional

Grandio blocs

K171200 · Voco GmbH · Dental
Aug 2017
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K171200 is an FDA 510(k) clearance for the Grandio blocs, 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 August 10, 2017, 108 days after receiving the submission on April 24, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K171200 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2017
Decision Date August 10, 2017
Days to Decision 108 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