Cleared Traditional

BIOPORTA G

K023391 · Wieland Dental + Technik GmbH & Co. KG · Dental
Dec 2002
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K023391 is an FDA 510(k) clearance for the BIOPORTA G, 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 December 10, 2002, 62 days after receiving the submission on October 9, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K023391 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2002
Decision Date December 10, 2002
Days to Decision 62 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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