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Cortex SATURN

Also known as: SATURN, Cortex Saturn

A bone-level implant from the Israeli maker Cortex, with an internal hexagon connection and a distinctive external body shape.

Quick facts

ManufacturerCortex Dental Implants Industries Ltd.Manufacturer-reported[1]
Body geometry"Saturn" external body shapeManufacturer-reported[1]
Thread design1-72 UNF thread, two starts, pitch 2.2Manufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceManufacturer documentation not located
ConnectionInternal hexagon connectionManufacturer-reported[1]
Available diametersØ3.8 mm platform documented on the product page; other widths exist in the range but were not capturedManufacturer-reported[1]
Available lengths8, 11.5, 13 and 16 mm (Ø3.8 platform)Manufacturer-reported[1]

Overview

SATURN is one of Cortex’s bone-level implants, with an internal hexagon connection and a two-start thread. The product page reviewed documents the Ø3.8 mm platform in four lengths from 8 to 16 mm; the wider platforms in the range were not captured here, so only the documented widths and lengths are recorded, and the surface and titanium grade are left as unknown. It is a conventional tapered implant rather than a special design like the company’s drill-less MAGIX.

Technology

Clinical evidence

We have not yet completed a system-specific evidence review for Cortex SATURN. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by Cortex at brand level and cover its implant range, not Cortex SATURN specifically. We show them here because that is the level at which regulators actually issue them.

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.

NumberDeviceHolderDate
K181580Cortex CAD/CAM AbutmentsCortex Dental Implants Industries , Ltd.2019-01-29
K163385Cortex Dental Implant SystemCortex Dental Implants Industries , Ltd.2017-08-29
K090709CORTEX DENTAL IMPLANT SYSTEMCortex 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.

NumberDeviceHolderDate
3007842672CORTEX 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

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