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Dentium Implantium

Also known as: Implantium

A tapered bone-level implant from Dentium with an internal hex conical connection, sharing its prosthetic platform with the SuperLine systems.

Quick facts

ManufacturerDentium Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone levelManufacturer-reported[1]
Body geometryTapered body with a uniform prosthetic platform across all diametersManufacturer-reported[1]
Thread designFixation threads described as synchronised with the implant body for initial stabilityManufacturer-reported[1]
Apex designThree tapered apical cutting flutes with a flat end, described as a three-blade self-tapping designManufacturer-reported[1]
MaterialUnalloyed commercially pure titanium grade 4Manufacturer-reported[1]
SurfaceS.L.A. — sandblasted with large grit and acid-etchedManufacturer-reported[1]
ConnectionInternal hex within a conical connection, with a single connection across all diameters and interchangeable abutments with SuperLine and SuperLine IIManufacturer-reported[1]
Platform switchingManufacturer documentation not located
Available diametersBody diameters of 3.4, 3.8, 4.3 and 4.8 mm, with platform diameters of 3.6, 4.0, 4.5 and 5.0 mmManufacturer-reported[1]
Available lengths8, 10, 12 and 14 mmManufacturer-reported[1]

Overview

Implantium is the older of Dentium’s main bone-level designs and is still listed alongside SuperLine rather than being withdrawn. It is a useful example of a distinction patients rarely see: Dentium quotes body diameter and platform diameter separately, so an implant listed at 4.3 mm carries a 4.5 mm platform. Since all three Dentium bone-level lines share a prosthetic connection, an older Implantium case can usually still be restored with current components.

Further detail

Geographic availabilityRequires manual verification

Clinical evidence

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