Osstem TS II SA
Also known as: TSII SA, TS II SA
A submerged, straight-walled bone-level implant in Osstem’s TS line, sharing the TS internal hex and 11-degree tapered connection.
Quick facts
| Manufacturer | Osstem Implant Co., Ltd.Manufacturer-reported[1] |
|---|---|
| Implant level | Bone level — described as a submerged-type implantManufacturer-reported[1] |
| Body geometry | Straight body design, which the catalogue says allows insertion depth to be adjusted easilyManufacturer-reported[1] |
| Thread design | Corkscrew thread with a self-threading effect, with small threads in the upper section for stability in soft boneManufacturer-reported[1] |
| Apex design | Manufacturer documentation not located |
| Material | Titanium — the instructions for use state that the fixture is made mainly of titaniumManufacturer-reported[1] |
| Surface | SA — sandblasted with alumina and acid-etchedManufacturer-reported[1] |
| Connection | Internal hex with an 11-degree tapered connectionManufacturer-reported[1] |
| Available diameters | Ø3.5, 4.0, 4.5 and 5.0 mmManufacturer-reported[1] |
| Available lengths | Ø3.5 in 8.5, 10, 11.5 and 13 mm; Ø4.0 and Ø4.5 in 7, 8.5, 10, 11.5 and 13 mm; Ø5.0 in 6, 7, 8.5, 10, 11.5 and 13 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
| Immediate protocol | Recommended insertion torque of 40 Ncm or lessManufacturer-reported[1] |
|---|---|
| Geographic availability | Requires manual verification |
Clinical evidence
We have not yet completed a system-specific evidence review for Osstem TS II 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 II 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.
| Number | Device | Holder | Date |
|---|---|---|---|
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023-09-23 |
| K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2022-09-08 |
| K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019-07-12 |
| K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017-05-22 |
| K161604 | OSSTEM Implant System | Osstem 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.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3031886796 | — | OSSTEM IMPLANT CO., LTD. | — |
| 3003394081 | — | OSSTEM IMPLANT CO., LTD. | — |
| 2157 device records | — | Osstem | — |
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
- [1]TS System — Catalog & User Manual (fixtures, abutments, instructions for use) — Osstem Implant UK Ltd, 2017. Accessed 2026-07-21.