Cleared Traditional

RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

K954512 · Lifecore Biomedical, Inc. · Dental
Feb 1996
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K954512 is an FDA 510(k) clearance for the RESTORE SELF TAPPING 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 February 23, 1996, 148 days after receiving the submission on September 28, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K954512 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1995
Decision Date February 23, 1996
Days to Decision 148 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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