Cleared Traditional

COWELL IMPLANT SYSTEM

K100850 · Cowellmedi Co., Ltd. · Dental
Dec 2010
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K100850 is an FDA 510(k) clearance for the COWELL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Cowellmedi Co., Ltd. (Brea, US). The FDA issued a Cleared decision on December 20, 2010, 269 days after receiving the submission on March 26, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K100850 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2010
Decision Date December 20, 2010
Days to Decision 269 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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