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Dentium SuperLine

Also known as: SuperLine

A tapered, double-threaded bone-level implant from Dentium with an internal hex inside a conical connection and a single prosthetic platform across all diameters.

Quick facts

ManufacturerDentium Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone levelManufacturer-reported[1]
Body geometryTapered bodyManufacturer-reported[1]
Thread designDouble thread, described as aggressive for efficiency across bone densitiesManufacturer-reported[1]
Apex designThree tapered apical cutting flutes with a flat end, stated to limit bone compression and reduce perforation riskManufacturer-reported[1]
MaterialUnalloyed commercially pure titanium grade 4, to ASTM F67Manufacturer-reported[1]
SurfaceS.L.A. — sandblasted with large grit and acid-etchedManufacturer-reported[1]
ConnectionInternal hex within a conical connection, with one prosthetic platform, one abutment screw and one hex driver across all diametersManufacturer-reported[1]
Platform switchingManufacturer documentation not located
Available diameters3.6, 4.0, 4.5, 5.0, 6.0 and 7.0 mmManufacturer-reported[1]
Available lengths8, 10, 12 and 14 mmManufacturer-reported[1]

Overview

SuperLine is Dentium’s tapered bone-level implant and the design most often meant when the brand is named. Its notable practical feature is that the prosthetic connection is the same size on every diameter, so a single abutment range and a single driver cover the system — a real advantage if components ever need replacing years later. The material is stated plainly as commercially pure grade 4 titanium rather than an alloy, which is worth knowing when comparing it with systems that use Ti-6Al-4V. Dentium also sells SuperLine II and Implantium, which share abutment compatibility with SuperLine but are separate implants.

Clinical positioning

What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.

Presented by Dentium as a bone-level implant suitable for immediate loadingManufacturer-reported

Further detail

Geographic availabilityRequires manual verification

Clinical evidence

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

Similar implant systems

Popular comparisons

The clearances below are held by Dentium at brand level and cover its implant range, not Dentium SuperLine 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) clearance11 records

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

NumberDeviceHolderDate
K213599SuperLineDentium Co., Ltd.2022-02-23
K172640Dentium Implantium & SuperLine ProstheticsDentium Co., Ltd.2018-05-14
K171622Dentium Ti-BaseDentium Co., Ltd.2018-01-11
K171126Implantium IIDentium Co., Ltd.2017-09-07
K170384Dentium NR Line CAD/CAM AbutmentsDentium Co., Ltd.2017-08-17
K160965SuperLineDentium Co., Ltd.2017-01-13
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.2016-12-16
K160828Dentium Implantium & SuperLine ProstheticsDentium Co., Ltd.2016-09-15
K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTSDentium Co., Ltd.2014-11-12
K060501IMPLANTIUM IIDentium Co., Ltd.2006-06-16
K041368DENTIUM CO., LTD. IMPLANTIUMDentium Co., Ltd.2004-07-29

Other1 record

Of 100 records we inspected, 82 are supplied sterile, 18 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.

NumberDeviceHolderDate
408 device recordsDentium

Clearance records for Dentium 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 Dentium.

Sources

Numbers match the citations beside each claim above.

Primary sources

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