Cleared Traditional

HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

K960288 · Lifecore Biomedical, Inc. · Dental
Mar 1996
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K960288 is an FDA 510(k) clearance for the HA & TPS 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 March 28, 1996, 66 days after receiving the submission on January 22, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K960288 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1996
Decision Date March 28, 1996
Days to Decision 66 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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