Dentium SuperLine
Also known as: SuperLine
A tapered, double-threaded bone-level implant from Dentium with an internal hex inside a conical connection and a single prosthetic platform across all diameters.
Quick facts
| Manufacturer | Dentium Co., Ltd.Manufacturer-reported[1][2] |
|---|---|
| Implant level | Bone levelManufacturer-reported[1] |
| Body geometry | Tapered bodyManufacturer-reported[1] |
| Thread design | Double thread, described as aggressive for efficiency across bone densitiesManufacturer-reported[1] |
| Apex design | Three tapered apical cutting flutes with a flat end, stated to limit bone compression and reduce perforation riskManufacturer-reported[1] |
| Material | Unalloyed commercially pure titanium grade 4, to ASTM F67Manufacturer-reported[1] |
| Surface | S.L.A. — sandblasted with large grit and acid-etchedManufacturer-reported[1] |
| Connection | Internal hex within a conical connection, with one prosthetic platform, one abutment screw and one hex driver across all diametersManufacturer-reported[1] |
| Platform switching | Manufacturer documentation not located |
| Available diameters | 3.6, 4.0, 4.5, 5.0, 6.0 and 7.0 mmManufacturer-reported[1] |
| Available lengths | 8, 10, 12 and 14 mmManufacturer-reported[1] |
Overview
Clinical positioning
What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.
Further detail
| Geographic availability | Requires manual verification |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Dentium SuperLine. 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 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.
| 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]SuperLine Implants — Dentium USA. Accessed 2026-07-21.
- [2]About Dentium USA — DentiumUSA. Accessed 2026-07-21.