Dentium

Also known as: Implantium, SuperLine

The implant brand of the Korean manufacturer Dentium, covering the SuperLine, Implantium and NR Line systems.

Key facts

Manufacturer	Dentium Co., Ltd.Verified spec[1][2]
Parent company	Dentium Co., Ltd., listed on the Korea Exchange under code 145720Verified spec[2]
Country	South KoreaVerified spec[2]
Headquarters	Seoul, South KoreaVerified spec[2][1]
Founded	June 2000, as Biostech Co., Ltd.; renamed Dentium in August 2002Verified spec[1][2]
Prosthetic ecosystem	Implant systems named by the manufacturer include SuperLine, SuperLine II, Implantium and NR LineManufacturer-reported[1]
Geographic availability	Sold in more than 80 countriesManufacturer-reported[1]

Overview

Dentium is a Korean manufacturer whose implants reach UK patients mainly through treatment abroad, and it remains listed on the Korea Exchange — unlike Osstem, which went private in 2023. Its two most commonly encountered systems, Implantium and SuperLine, are separate designs rather than successive names for the same product, so the system name matters for later restorative work. The company traded as Biostech until 2002, which occasionally shows up in older regulatory paperwork and can look like a different manufacturer entirely.

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.

Number	Device	Holder	Date
K213599	SuperLine	Dentium Co., Ltd.	2022-02-23
K172640	Dentium Implantium & SuperLine Prosthetics	Dentium Co., Ltd.	2018-05-14
K171622	Dentium Ti-Base	Dentium Co., Ltd.	2018-01-11
K171126	Implantium II	Dentium Co., Ltd.	2017-09-07
K170384	Dentium NR Line CAD/CAM Abutments	Dentium Co., Ltd.	2017-08-17
K160965	SuperLine	Dentium Co., Ltd.	2017-01-13
K161713	Dentium CAD/CAM Abutments	Dentium Co., Ltd.	2016-12-16
K160828	Dentium Implantium & SuperLine Prosthetics	Dentium Co., Ltd.	2016-09-15
K141457	DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS	Dentium Co., Ltd.	2014-11-12
K060501	IMPLANTIUM II	Dentium Co., Ltd.	2006-06-16
K041368	DENTIUM CO., LTD. IMPLANTIUM	Dentium 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.

Number	Device	Holder	Date
408 device records	—	Dentium	—

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

[1]About Dentium USA — DentiumUSA. Accessed 2026-07-21.

Additional references

[2]Dentium Co., Ltd. (KRX: 145720) company profile — StockAnalysis. Accessed 2026-07-21.