Cleared Traditional

REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM

K991114 · Lifecore Biomedical, Inc. · Dental
Jul 1999
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K991114 is an FDA 510(k) clearance for the REGULAR DIAMETER SINGLE STAGE (RDS) 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 July 14, 1999, 104 days after receiving the submission on April 1, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K991114 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 1999
Decision Date July 14, 1999
Days to Decision 104 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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