Cleared Traditional

K071148 - ATLAS IMPLANT SYSTEM
(FDA 510(k) Clearance)

K071148 · Cowellmedi Co., Ltd. · Dental

Feb 2008

Decision

288d

Days

Class 2

Risk

K071148 is an FDA 510(k) clearance for the ATLAS IMPLANT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).

Submitted by Cowellmedi Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on February 6, 2008, 288 days after receiving the submission on April 24, 2007.

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

Submission Details

510(k) Number	K071148 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2007
Decision Date	February 06, 2008
Days to Decision	288 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF