Cleared Traditional

AGC CEM

K030168 · Wieland Dental + Technik GmbH & Co. KG · Dental
Mar 2003
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K030168 is an FDA 510(k) clearance for the AGC CEM, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on March 21, 2003, 63 days after receiving the submission on January 17, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K030168 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2003
Decision Date March 21, 2003
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275