Cleared Traditional

ATLAS IMPLANT SYSTEM - WIDE PLUS

K090054 · Cowellmedi Co., Ltd. · Dental
Jul 2009
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K090054 is an FDA 510(k) clearance for the ATLAS IMPLANT SYSTEM - WIDE PLUS, 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 July 29, 2009, 202 days after receiving the submission on January 8, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K090054 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2009
Decision Date July 29, 2009
Days to Decision 202 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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