Trausim
Also known as: Trausim Dental Implant System
The implant brand of Jiangsu Trausim Medical Instrument Co., Ltd. of China, covering bone-level and tissue-level fixtures.
Key facts
| Manufacturer | Jiangsu Trausim Medical Instrument Co., Ltd.Verified spec[1] |
|---|---|
| Country | ChinaVerified spec[1] |
| Available diameters | Manufacturer documentation not located(Fixture diameters are not listed in the public FDA 510(k) summary and we did not locate manufacturer documentation stating them.) |
| Available lengths | Manufacturer documentation not located |
| manufacturingCountry | ChinaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
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.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.