Cleared Traditional

SIMIDUR KF PLUS

K020194 · Wieland Dental + Technik GmbH & Co. KG · Dental
Mar 2002
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K020194 is an FDA 510(k) clearance for the SIMIDUR KF PLUS, 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 15, 2002, 52 days after receiving the submission on January 22, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K020194 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2002
Decision Date March 15, 2002
Days to Decision 52 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