Cleared Traditional

ALLUX

K050203 · Wieland Dental + Technik GmbH & Co. KG · Dental
Feb 2005
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K050203 is an FDA 510(k) clearance for the ALLUX, 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 14, 2005, 17 days after receiving the submission on January 28, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K050203 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2005
Decision Date February 14, 2005
Days to Decision 17 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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