Trausim Dental Implant System

Also known as: Trausim Implant, Trausim BL, Trausim TL

The FDA-cleared implant system of Jiangsu Trausim Medical Instrument of China, offered in bone-level and tissue-level designs.

Compare this implant

Quick facts

Manufacturer	Jiangsu Trausim Medical Instrument Co., Ltd.Verified spec[1]
Material	Manufacturer documentation not located(The public FDA 510(k) summary for this clearance is the clearance letter and indications only; it does not state the fixture material.)
Surface	Manufacturer documentation not located
Connection	Manufacturer documentation not located
Available diameters	Manufacturer documentation not located(Not listed in the public FDA summary; a trade catalogue is not a sufficient source for a dimension.)
Available lengths	Manufacturer documentation not located

Overview

Trausim is one of the more established Chinese-owned implant systems, cleared by the US FDA in 2014 and offered in bone-level and tissue-level forms. It is a useful example of where documentation runs out: the public regulatory record confirms the system exists and is cleared for the usual indications, but it does not publish the fixture material, surface or dimensions, and Chinese domestic brands are poorly documented in English. Rather than repeat a trade-catalogue figure, we publish what is confirmed and mark the specifications as unverified.

Technology

BrandTrausim

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.

Indicated for surgical and restorative placement in the upper or lower jaw to support prosthetic devices and restore chewing functionVerified spec

Further detail

Country	ChinaVerified spec[1]

Clinical evidence

We have not yet completed a system-specific evidence review for Trausim Dental Implant System. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by Trausim at brand level and cover its implant range, not Trausim Dental Implant System 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) clearance1 record

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

Number	Device	Holder	Date
K140202	TRAUSIM DENTAL IMPLANT SYSTEM	Jiangsu Trausim Medical Instrument	2014-12-12

Other1 record

Registered device establishment in China. 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
3011587077	—	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	—

Clearance records for Trausim 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 Trausim.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]FDA 510(k) K140202 — Trausim Dental Implant System — U.S. Food & Drug Administration, 2014. Accessed 2026-07-21.