Cleared Traditional

XIVE TG ABUTMENTS

K032302 · Friadent GmbH · Dental
Oct 2003
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K032302 is an FDA 510(k) clearance for the XIVE TG ABUTMENTS, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on October 2, 2003, 69 days after receiving the submission on July 25, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K032302 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2003
Decision Date October 02, 2003
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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