Cleared Traditional

THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM

K003226 · Lifecore Biomedical, Inc. · Dental
Jan 2001
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K003226 is an FDA 510(k) clearance for the THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT 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 January 12, 2001, 88 days after receiving the submission on October 16, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K003226 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2000
Decision Date January 12, 2001
Days to Decision 88 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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