Cleared Traditional

K090054 - ATLAS IMPLANT SYSTEM - WIDE PLUS (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090054 · Cowellmedi Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
202d
Days
Class 2
Risk

K090054 is an FDA 510(k) clearance for the ATLAS IMPLANT SYSTEM - WIDE PLUS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cowellmedi Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on July 29, 2009 after a review of 202 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Cowellmedi Co., Ltd. devices

Submission Details

510(k) Number K090054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 127d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1541
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