Dentium
Also known as: Dentium Co., Ltd., Biostech Co., Ltd.
A South Korean dental implant manufacturer listed on the Korea Exchange, whose systems include Implantium, SuperLine and NR Line.
Key facts
| Headquarters | Seoul, South Korea; its United States subsidiary DentiumUSA operates from Cypress, CaliforniaVerified spec[1][2] |
|---|---|
| Country | South KoreaVerified spec[2] |
| Founded | June 2000; the company was formerly named Biostech Co., Ltd. and adopted the Dentium name in August 2002Verified spec[1][2] |
| Ownership | Publicly listed on the Korea Exchange under code 145720Verified spec[2]Confirmed from a listed-company reference profile rather than an exchange filing we hold directly |
| Brand | Dentium, covering the SuperLine, SuperLine II, Implantium and NR Line implant systemsManufacturer-reported[1] |
| Geographic availability | Products sold in more than 80 countriesManufacturer-reported[1] |
Overview
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) clearance22 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 |
| K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | 2020-01-23 |
| K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | 2019-11-04 |
| 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 |
| K160483 | Burn-out Cylinder and Angled Screw Abutments | Dentium Co., Ltd. | 2016-08-05 |
| K153268 | NR Line Implant System | Dentium Co., Ltd. | 2016-07-20 |
| K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS | Dentium Co., Ltd. | 2014-11-12 |
| K112045 | SIMPLELINE II ABUTMENT SYSTEM | Dentium Co., Ltd. | 2012-01-26 |
| K111162 | SLIM ONEBODY SYSTEM | Dentium Co., Ltd. | 2012-01-13 |
| K102308 | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS | Dentium Co., Ltd. | 2010-11-22 |
| K070228 | IMPLANTIUM PROSTHETICS | Dentium Co., Ltd. | 2007-11-20 |
| K052957 | IMPLANTIUM PROSTHETICS | Dentium Co., Ltd. | 2006-07-27 |
| K060500 | SPEEDY ORTHODONTIC SCREW | Dentium Co., Ltd. | 2006-06-16 |
| K060501 | IMPLANTIUM II | Dentium Co., Ltd. | 2006-06-16 |
| K052823 | IMPLANTIUM ABUTMENTS | Dentium, Inc. | 2006-02-21 |
| K041368 | DENTIUM CO., LTD. IMPLANTIUM | Dentium Co., Ltd. | 2004-07-29 |
Other1 record
Of 200 records we inspected, 158 are supplied sterile, 42 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (200). 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.