Cleared Abbreviated

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS

K051614 · Lifecore Biomedical, Inc. · Dental
Sep 2005
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K051614 is an FDA 510(k) clearance for the PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS, 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 9, 2005, 84 days after receiving the submission on June 17, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K051614 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2005
Decision Date September 09, 2005
Days to Decision 84 days
Submission Type Abbreviated
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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