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Dentium NR Line

Also known as: NR Line, Dentium NR

A narrow-diameter bone-level implant from Dentium with a 3.1 mm body and a 10-degree internal conical connection with a square index.

Quick facts

ManufacturerDentium Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone levelManufacturer-reported[1]
Body geometryNarrow, double-threaded tapered bodyManufacturer-reported[1]
Thread designDouble threadManufacturer-reported[1]
Apex designThree long cutting flutes running from apical to coronal, with a flat apical endManufacturer-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 conical connection of 10 degrees with a square indexManufacturer-reported[1]
Platform switchingManufacturer documentation not located
Available diametersBody diameter 3.1 mm, with platform diameters of 3.2 mm and 3.6 mmManufacturer-reported[1]
Available lengths9, 10 and 11 mmManufacturer-reported[1]

Overview

NR Line is Dentium’s narrow implant and, unlike the SuperLine family, it uses a different connection — a 10-degree internal cone with a square index rather than the internal hex used elsewhere in the range. That matters for anyone assuming that all Dentium components are interchangeable; they are not. The available lengths are short by the standards of the rest of the range, at 9 to 11 mm, which is typical for narrow fixtures placed in thin ridges. Narrow-diameter implants have their own body of evidence and are usually recommended for lower-load sites.

Further detail

Narrow implant optionA narrow-diameter implant at 3.1 mm body diameterManufacturer-reported[1]
Geographic availabilityRequires manual verification

Clinical evidence

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

Similar implant systems

The clearances below are held by Dentium at brand level and cover its implant range, not Dentium NR Line 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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