Cleared Traditional

PORTA REFLEX

K040672 · Wieland Dental + Technik GmbH & Co. KG · Dental
May 2004
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K040672 is an FDA 510(k) clearance for the PORTA REFLEX, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on May 27, 2004, 73 days after receiving the submission on March 15, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K040672 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2004
Decision Date May 27, 2004
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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