Cleared Traditional

K090054 - ATLAS IMPLANT SYSTEM - WIDE PLUS

K090054 is an FDA 510(k) clearance for ATLAS IMPLANT SYSTEM - WIDE PLUS, manufactured by Cowellmedi Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 202-day FDA review.

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

FDA 510(k) Submission Details - K090054

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.

DZE Device Classification - Class 2, Special Controls

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 759
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