Cleared Traditional

PORTA PRESSOVER

K031264 · Wieland Dental + Technik GmbH & Co. KG · Dental
Jun 2003
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K031264 is an FDA 510(k) clearance for the PORTA PRESSOVER, 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 June 12, 2003, 52 days after receiving the submission on April 21, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K031264 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2003
Decision Date June 12, 2003
Days to Decision 52 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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