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Dentium SuperLine II

Also known as: SuperLine II

A tapered bone-level implant from Dentium with a sharper, deeper thread and increased pitch compared with SuperLine, sharing the same internal hex conical platform.

Quick facts

ManufacturerDentium Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone levelManufacturer-reported[1]
Body geometryDouble-threaded tapered bodyManufacturer-reported[1]
Thread designSharper and deeper threads with an increased pitch relative to the earlier SuperLineManufacturer-reported[1]
Apex designThree long cutting flutes running from apical to coronal, with a flat apical endManufacturer-reported[1]
MaterialCommercially 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 connection and one abutment screw shared across all diameters and across SuperLine, SuperLine II and ImplantiumManufacturer-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 lengths7, 8, 10, 12 and 14 mmManufacturer-reported[1]

Overview

The “II” in SuperLine II describes a revised thread rather than a replacement product — Dentium continues to list SuperLine, SuperLine II and Implantium together, and the three share a prosthetic platform, so abutments made for one fit the others. The revision is a sharper, deeper thread with a wider pitch, which is the usual way manufacturers pursue primary stability in less dense bone. Because the connection is unchanged, a laboratory or clinician working on an older Dentium case will generally find the components still available.

Further detail

Predecessor systemDentium presents SuperLine, SuperLine II and Implantium alongside one another with interchangeable abutments; it does not state that SuperLine II replaces SuperLineManufacturer-reported[1]
Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for Dentium SuperLine II. 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 II 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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