Cleared Traditional

K090709 - CORTEX DENTAL IMPLANT SYSTEM

K090709 is the FDA 510(k) clearance for CORTEX DENTAL IMPLANT SYSTEM by Cortex Dental Implants Industries , Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K090709 · Cortex Dental Implants Industries , Ltd. · Dental device
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Jul 2009
Decision
111d
Days
Class 2
Risk

K090709 is an FDA 510(k) clearance for the CORTEX DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cortex Dental Implants Industries , Ltd. (Mizpe Aviv, M.P. Misgav, IL). The FDA issued a Cleared decision on July 7, 2009 after a review of 111 days - within the typical 510(k) review window.

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 Cortex Dental Implants Industries , Ltd. devices

Submission Details

510(k) Number K090709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2009
Decision Date July 07, 2009
Days to Decision 111 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
16d faster than avg
Panel avg: 127d · This submission: 111d
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 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K090709.
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · Straumann USA · Feb 2010
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
K082843 · Dentis Co., Ltd. · Jun 2009
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009