Cleared Traditional

LIFECORE SINGLE TOOTH ABUTMENT SYSTEM

K993894 · Lifecore Biomedical, Inc. · Dental
Mar 2000
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K993894 is an FDA 510(k) clearance for the LIFECORE SINGLE TOOTH ABUTMENT 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 8, 2000, 113 days after receiving the submission on November 16, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K993894 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1999
Decision Date March 08, 2000
Days to Decision 113 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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