Cleared Traditional

ECO E4

K022469 · Wieland Dental + Technik GmbH & Co. KG · Dental
Sep 2002
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K022469 is an FDA 510(k) clearance for the ECO E4, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on September 18, 2002, 54 days after receiving the submission on July 26, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K022469 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2002
Decision Date September 18, 2002
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060