Cleared Traditional

RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM

K954819 · Lifecore Biomedical, Inc. · Dental
Jan 1996
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K954819 is an FDA 510(k) clearance for the RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS 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, 83 days after receiving the submission on October 20, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K954819 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1995
Decision Date January 11, 1996
Days to Decision 83 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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