Cleared Traditional

XAWEX G 100

K050903 · Wieland Dental + Technik GmbH & Co. KG · Dental
Jun 2005
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K050903 is an FDA 510(k) clearance for the XAWEX G 100, 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 June 23, 2005, 73 days after receiving the submission on April 11, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K050903 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2005
Decision Date June 23, 2005
Days to Decision 73 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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