Cleared Traditional

Admira Fusion x-base

K170896 · Voco GmbH · Dental
Jun 2017
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K170896 is an FDA 510(k) clearance for the Admira Fusion x-base, 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 June 29, 2017, 94 days after receiving the submission on March 27, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K170896 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2017
Decision Date June 29, 2017
Days to Decision 94 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