Cleared Abbreviated

ZENOFLEX DIMENSION

K103773 · Wieland Dental + Technik GmbH & Co. KG · Dental
Mar 2011
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K103773 is an FDA 510(k) clearance for the ZENOFLEX DIMENSION, 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 March 16, 2011, 79 days after receiving the submission on December 27, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K103773 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2010
Decision Date March 16, 2011
Days to Decision 79 days
Submission Type Abbreviated
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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