Cleared Traditional

Admira Fusion 5

K230877 · Voco GmbH · Dental
Jul 2023
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K230877 is an FDA 510(k) clearance for the Admira Fusion 5, 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 July 13, 2023, 105 days after receiving the submission on March 30, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K230877 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2023
Decision Date July 13, 2023
Days to Decision 105 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