Cleared Traditional

ZIROX

K051249 · Wieland Dental + Technik GmbH & Co. KG · Dental
Jul 2005
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K051249 is an FDA 510(k) clearance for the ZIROX, 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 July 22, 2005, 67 days after receiving the submission on May 16, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K051249 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2005
Decision Date July 22, 2005
Days to Decision 67 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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