Cortex
Also known as: Cortex Dental
The Israeli dental implant brand of Cortex Dental Implants Industries, including the MAGIX drill-less implant and the SATURN line.
Key facts
| Manufacturer | Cortex Dental Implants Industries Ltd.Verified spec[1] |
|---|---|
| Country | IsraelVerified spec[1] |
| Manufacturer-described indication | Range spans MAGIX (marketed as a drill-less implant), DYNAMIX, CLASSIX, SATURN and one-piece implantsManufacturer-reported[1] |
| manufacturingCountry | IsraelVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance3 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
Other1 record
Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3007842672 | — | CORTEX DENTAL IMPLANTS INDUSTRIES LTD. | — |
Clearance records for Cortex were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Cortex.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]About Us — Cortex Dental — Cortex Dental Implants Industries Ltd.. Accessed 2026-07-22.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.