Cleared Traditional

THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM

K032495 · Lifecore Biomedical, Inc. · Dental
Sep 2003
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K032495 is an FDA 510(k) clearance for the THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on September 17, 2003, 35 days after receiving the submission on August 13, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K032495 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2003
Decision Date September 17, 2003
Days to Decision 35 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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