Cleared Traditional

K002037 - LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
(FDA 510(k) Clearance)

K002037 · Lifecore Biomedical, Inc. · Dental

May 2001

Decision

315d

Days

Class 2

Risk

K002037 is an FDA 510(k) clearance for the LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS. This device is classified as 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 May 16, 2001, 315 days after receiving the submission on July 5, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K002037 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2000
Decision Date	May 16, 2001
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF