Cleared Traditional

GrandioSO x-tra

K181312 · Voco GmbH · Dental
Aug 2018
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K181312 is an FDA 510(k) clearance for the GrandioSO x-tra, 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 22, 2018, 97 days after receiving the submission on May 17, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K181312 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2018
Decision Date August 22, 2018
Days to Decision 97 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