# K090709: Cortex Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Dental Implants Industries, Ltd.
- Decided: Jul 7, 2009 after 111 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K925765 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 1.
- K080162: Uno - One Piece Screw-Type Dental Implant, Mis Implants Technologies, Ltd. (2008) Summary page 2.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.

## Indications for use
The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

Source page: https://510kreport.com/device/K090709
Methodology: https://510kreport.com/methodology