Cleared Traditional

RENOVA INTERNAL HEX IMPLANT SYSTEM

K032774 · Lifecore Biomedical, Inc. · Dental
Nov 2003
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K032774 is an FDA 510(k) clearance for the RENOVA INTERNAL HEX 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 November 26, 2003, 79 days after receiving the submission on September 8, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K032774 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2003
Decision Date November 26, 2003
Days to Decision 79 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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