Cleared Traditional

SIMIDUR SUPERIOR

K040436 · Wieland Dental + Technik GmbH & Co. KG · Dental
Mar 2004
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K040436 is an FDA 510(k) clearance for the SIMIDUR SUPERIOR, 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 March 5, 2004, 15 days after receiving the submission on February 19, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K040436 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2004
Decision Date March 05, 2004
Days to Decision 15 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