Cleared Traditional

ZENOSTAR MAGIC GLAZE

K103494 · Wieland Dental + Technik GmbH & Co. KG · Dental
Feb 2011
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K103494 is an FDA 510(k) clearance for the ZENOSTAR MAGIC GLAZE, 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 February 16, 2011, 79 days after receiving the submission on November 29, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K103494 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2010
Decision Date February 16, 2011
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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