Cleared Abbreviated

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

K041655 · Cowellmedi Co., Ltd. · Dental
Sep 2004
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K041655 is an FDA 510(k) clearance for the BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS), a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Cowellmedi Co., Ltd. (Newington, US). The FDA issued a Cleared decision on September 8, 2004, 82 days after receiving the submission on June 18, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K041655 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2004
Decision Date September 08, 2004
Days to Decision 82 days
Submission Type Abbreviated
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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