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Osstem TS IV SA

Also known as: TSIV SA, TS IV SA

A submerged, tapered bone-level implant in Osstem’s TS line with a wider thread pitch, presented by the manufacturer for soft bone and the posterior maxilla.

Quick facts

ManufacturerOsstem Implant Co., Ltd.Manufacturer-reported[1][2]
Implant levelBone level — described as a submerged-type implantManufacturer-reported[1]
Body geometryTapered body, sharing the TS connection with the rest of the lineManufacturer-reported[1]
Thread designCorkscrew thread with a large pitch — 0.8 mm at Ø4.0, 1.0 mm at Ø4.5 and 1.2 mm at Ø5.0 — with smaller threads in the upper part for fixation in soft bone; because the pitch is large, Osstem advises reducing the placement speed to 15 rpm or lessManufacturer-reported[1]
Apex designSharp apex design that the catalogue states allows placement in D4 bone after only 2.0/3.0 mm drillingManufacturer-reported[1]
MaterialTitanium — the instructions for use state that the fixture is made mainly of titaniumManufacturer-reported[1]No titanium grade is named in the instructions for use.
SurfaceSA — sandblasted with alumina and acid-etchedManufacturer-reported[2][1]
ConnectionInternal hex with an 11-degree tapered connectionManufacturer-reported[1]
Platform switchingManufacturer documentation not located(Osstem describes platform switching for the TS line generally; we have not located a statement specific to TSIV SA.)
Available diametersØ4.0, 4.5, 5.0, 6.0 and 7.0 mmManufacturer-reported[1]
Available lengths7, 8.5, 10, 11.5 and 13 mmManufacturer-reported[1]

Overview

TS IV is the soft-bone member of Osstem’s TS family rather than a newer or better version of TS III — the Roman numeral is a design variant, not a generation. Its distinguishing feature is a much larger thread pitch, specified separately for each diameter, which lets the implant cut a coarser path and gain grip where bone is poorly mineralised. That same coarse thread is why Osstem tells clinicians to slow the handpiece to 15 rpm or less during placement, since the implant advances quickly. It shares the TS internal hex and 11-degree taper, so prosthetic components are common across the line.

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.

Described by Osstem as a fixture for the maxillary sinus region and soft bone, with a fixture of Ø4.5 mm or more recommended for single posterior restorationsManufacturer-reported

Further detail

Immediate protocolRecommended placement torque below 40 NcmManufacturer-reported[1]
Predecessor systemNot publicly verified
Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for Osstem TS IV 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 IV 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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