Cleared Traditional

K163385 - Cortex Dental Implant System (FDA 510(k) Clearance)

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

K163385 · Cortex Dental Implants Industries , Ltd. · Dental device
Aug 2017
Decision
270d
Days
Class 2
Risk

K163385 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. (Shlomi, IL). The FDA issued a Cleared decision on August 29, 2017 after a review of 270 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.

Submission Details

510(k) Number K163385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2016
Decision Date August 29, 2017
Days to Decision 270 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 158d · This submission: 270d
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 69
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