Cleared Special

GrandioSO Unlimited

K251239 · Voco GmbH · Dental
May 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251239 is an FDA 510(k) clearance for the GrandioSO Unlimited, 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 May 21, 2025, 29 days after receiving the submission on April 22, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K251239 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2025
Decision Date May 21, 2025
Days to Decision 29 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