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Osstem TS III SA

Also known as: TSIII SA, TS III SA, Osstem TSIII

A submerged, tapered bone-level implant from Osstem Implant’s TS line, using an internal hex with an 11-degree tapered connection and the sandblasted, acid-etched SA surface.

Quick facts

ManufacturerOsstem Implant Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone level — the catalogue describes TSIII SA as a submerged-type implantManufacturer-reported[1]
Body geometryTapered body design, stated to give initial fixation at placementManufacturer-reported[1]
Thread designCorkscrew thread with a self-threading effect, with smaller threads in the upper part of the body intended for stability in soft boneManufacturer-reported[1]
Apex designApex design described as giving initial fixation in extraction sites and over the apical 3 mmManufacturer-reported[1]
MaterialTitanium — the instructions for use state that the fixture is made mainly of titaniumManufacturer-reported[1]The instructions for use do not name a titanium grade for the fixture.
SurfaceSA — sandblasted with alumina and acid-etchedManufacturer-reported[2][1]
ConnectionInternal hex with an 11-degree tapered connection; a mini connection is used on Ø3.0 and Ø3.5 fixtures and a regular connection on Ø4.0 and aboveManufacturer-reported[1]
Platform switchingOsstem lists platform switching among the features of the TSIII SA fixtureManufacturer-reported[2]
Available diametersØ3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0 mmManufacturer-reported[1]Read from the fixture ordering tables in the TS System catalogue.
Available lengths6, 7, 8.5, 10, 11.5 and 13 mm at Ø4.0 and above; Ø3.0 and Ø3.5 from 8.5 to 13 mm; Ø5.0 additionally in 4 mm and 5 mmManufacturer-reported[1]Availability varies by diameter; taken from the fixture product codes in the catalogue.

Overview

TS III SA is the fixture most people mean when they say “Osstem implant”, and it is a conventional tapered bone-level design rather than anything unusual: an internal hex sitting inside an 11-degree taper, a corkscrew thread, and a blasted and acid-etched surface. The letters after the name matter more than the name itself — SA is the plain sandblasted and acid-etched surface, while CA is the same physical surface stored in solution so that it stays chemically active, and the two are not interchangeable when reading a treatment plan. The range is unusually wide, running from Ø3.0 up to Ø7.0 mm and including 4 mm and 5 mm ultra-short fixtures at Ø5.0, and Osstem’s own instructions place real restrictions on those shortest options. A patient told they are receiving “an Osstem TS” has therefore been told very little; the diameter, the length and the surface variant are the parts that describe the actual implant.

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.

Presented by Osstem as a general-purpose fixture for a wide range of cases, with a fixture of Ø4.5 mm or more recommended for single posterior restorationsManufacturer-reported

Further detail

Short implant optionExtra-short options are offered; the instructions for use restrict implants shorter than 7 mm with a diameter of 5 mm or more to the molar region and advise splinting and a longer healing periodManufacturer-reported[1]
Immediate protocolRecommended placement torque below 40 Ncm; the catalogue states the fixture acquires initial fixation for immediate loading in soft boneManufacturer-reported[1]
Geographic availabilityRequires manual verification(Regulatory clearance and distribution vary by market.)

Clinical evidence

We have not yet completed a system-specific evidence review for Osstem TS III SA. Insufficient system-specific evidence How we grade evidence

Similar implant systems

Popular comparisons

The clearances below are held by Osstem at brand level and cover its implant range, not Osstem TS III SA 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) clearance5 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K222778Osstem Implant SystemOsstem Implant Co., Ltd.2023-09-23
K221684Osstem Abutment SystemOsstem Implant Co., Ltd.2022-09-08
K182091Osstem Abutment SystemOsstem Implant Co., Ltd.2019-07-12
K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd.2017-05-22
K161604OSSTEM Implant SystemOsstem Implant Co., Ltd.2016-10-17

Other3 records

Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

NumberDeviceHolderDate
3031886796OSSTEM IMPLANT CO., LTD.
3003394081OSSTEM IMPLANT CO., LTD.
2157 device recordsOsstem

Clearance records for Osstem 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 Osstem.

Sources

Numbers match the citations beside each claim above.

Primary sources

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