Cortex Dental Implants Industries

Also known as: Cortex, Cortex Dental

An Israeli dental implant manufacturer that produces the MAGIX, DYNAMIX, CLASSIX and SATURN implant lines.

Key facts

Country	IsraelVerified spec[1]
Headquarters	Manufacturer documentation not located(The about page identifies the company as Israeli but does not state a city on the reviewed page.)
Founded	Manufacturer documentation not located
regulatoryApproval	States CE marking via BSI (CE2797), FDA 510(k) clearance for US sale and ISO 13485 certificationManufacturer-reported[1]
Geographic availability	Operates through subsidiaries in China, Latin America and the USA plus a distributor networkManufacturer-reported[1]
manufacturingCountry	IsraelVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Cortex Dental is an Israeli manufacturer whose range spans conventional tapered implants and the MAGIX design it markets as drill-less. It presents itself as CE-marked and FDA-cleared, which places it among the Israeli exporters alongside Alpha-Bio, MIS, Adin and Noris. The company’s own material is the source for these regulatory statements; they describe market authorisation rather than comparative clinical outcome.

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) clearance4 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K181580	Cortex CAD/CAM Abutments	Cortex Dental Implants Industries , Ltd.	2019-01-29
K163385	Cortex Dental Implant System	Cortex Dental Implants Industries , Ltd.	2017-08-29
K131258	SATURN DENTAL IMPLANT	Cortex Dental Implants Industries , Ltd.	2014-03-17
K090709	CORTEX DENTAL IMPLANT SYSTEM	Cortex Dental Implants Industries , Ltd.	2009-07-07

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 Dental Implants Industries 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 Dental Implants Industries.

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.