# K163385: Cortex Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Dental Implants Industries, Ltd.
- Decided: Aug 29, 2017 after 270 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K182615: Surgikor Dental Implant System (2019), 3 descendants of its own
- K233271: OsseOne Dental Implant System (2025), 0 descendants of its own
- K242217: Surcam Dental Implant System (2025), 0 descendants of its own
- K240803: Surgikor Fixation One, Abutment Blanks and Abutments (2024), 0 descendants of its own

## Indications for use
Cortex Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading 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 device 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/K163385
Methodology: https://510kreport.com/methodology