Manufacturer registered with FDA
Kontour (Xi'an) Medical Technology Co., Ltd.
Xi'an, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1158 registrations outside the US
- Establishments
- 1China
Registered in 11 markets
Where regulators' registries name Kontour (Xi'an) Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Kontour (Xi'an) Medical Technology Co., Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Registration holder | KONTOUR (XI´AN) MEDICAL TECHNOLOGY CO.,LTDKONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD. | 32 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Kontour (Xi'an) Medical Technology Co., Ltd. | 6 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Kontour (Xi'an) Medical Technology Co., Ltd. | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kontour(Xi'an) Medical Technology Co., Ltd.Kontour (Xi'an) Medical Technology Co., Ltd. | 4 | 2018–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Kontour (Xi’an) Medical Technology Co., Ltd. | 3 | 2017–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Kontour (Xi'an) Medical Technology Co. Ltd. | 2 | 2024–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD. | 2 | 2022–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Kontour (Xi'an) Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KONTOUR (XI´AN) MEDICAL TECHNOLOGY Co., Ltd. | 1 | 2019–2019 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Kontour (Xi'an) Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Kontour (Xi'an) Medical Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | BIOMESHBioplate Rigid Fixation SystemModification to Bioplate Rigid Fixation SystemModified Screw DesignModified Sterile Plate and Screw ConfigurationSterile Plate and Screw Configuration | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3011423165 | Xi'an Shaanxi, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062728). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.