Jiangsu Trausim Medical Instrument

Also known as: Trausim, Jiangsu Trausim Medical Instrument Co., Ltd.

A Chinese dental implant manufacturer in Changzhou, Jiangsu, part of the Fulong Holdings group, producing bone-level and tissue-level implant systems.

Key facts

Manufacturer	Jiangsu Trausim Medical Instrument Co., Ltd.Verified spec[1]
Country	ChinaVerified spec[1]
Headquarters	Changzhou, Jiangsu Province, China (Niutang Town, Wujin District)Verified spec[1]
Ownership	Described by the company as a wholly-owned subsidiary of the Fulong Holdings groupManufacturer-reported[2]
Founded	Manufacturer documentation not located(Reported as 2010 in trade directories; not confirmed on a company document we could open.)
manufacturingCountry	ChinaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Trausim is a Changzhou manufacturer and one of the larger Chinese-owned implant makers, cleared by the US FDA in 2014. It sits within the Fulong Holdings group and produces both bone-level and tissue-level fixtures, plus components designed to be compatible with mainstream systems such as Straumann and Nobel Biocare. Chinese domestic implants are poorly documented in English, and Trausim’s public FDA summary does not list fixture diameters or lengths, so we publish the company record but leave those dimensions unverified rather than repeat a trade catalogue figure.

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 Jiangsu Trausim Medical Instrument 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 Jiangsu Trausim Medical Instrument.

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.
[2]Jiangsu Trausim Medical Instrument — About — Jiangsu Trausim Medical Instrument Co., Ltd.. Accessed 2026-07-21.
[3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.