Cleared Traditional

RESTORE HA DENTAL IMPLANT SYSTEM

K954865 · Lifecore Biomedical, Inc. · Dental
Jan 1996
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K954865 is an FDA 510(k) clearance for the RESTORE HA 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 11, 1996, 80 days after receiving the submission on October 23, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K954865 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1995
Decision Date January 11, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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