Cleared Traditional

zenostar MO, Zenostar T, Zenostar VisualiZr

K142233 · Wieland Dental + Technik GmbH & Co. KG · Dental
Jan 2015
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K142233 is an FDA 510(k) clearance for the zenostar MO, Zenostar T, Zenostar VisualiZr, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on January 5, 2015, 145 days after receiving the submission on August 13, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K142233 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2014
Decision Date January 05, 2015
Days to Decision 145 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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