Cleared Traditional

Structur CAD

K201090 · Voco GmbH · Dental
Sep 2020
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K201090 is an FDA 510(k) clearance for the Structur CAD, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on September 9, 2020, 139 days after receiving the submission on April 23, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K201090 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2020
Decision Date September 09, 2020
Days to Decision 139 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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