Manufacturer registered with FDA
Shenzhen Xiangtong Co., Ltd.
Shenzhen, China. Lists 1 dental device type with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 32023–2025
- Markets registered in
- 926 registrations outside the US
- Establishments
- 2China
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Shenzhen Xiangtong 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 | Shenzhen Xiangtong Co., Ltd. | 3 clearances | 2023–2025 | Below |
| Brazil | ANVISA | Manufacturer | SHENZHEN XIANGTONG CO.,LTD.SHENZHEN XIANGTONG CO., LTD | 13 | 2017–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | SHENZHEN XIANGTONG CO.,LTD. | 3 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SHENZHEN XIANGTONG CO.,LTD. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN XIANGTONG CO., LTDSHENZHEN XIANGTONG CO., LTD. · Shenzhen Xiangtong Co., Ltd. | 3 | 2021–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHENZHEN XIANGTONG CO., LTD | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SHENZHEN XIANGTONG CO.,LTD. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shenzhen Xiangtong Co., Ltd. | 1 | 2024–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shenzhen Xiangtong Co., Ltd | 1 | 2026–2026 | 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 Shenzhen Xiangtong 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Coloring LiquidGlass CeramicX-cera Pre-shaded Zirconia BlanksX-Cera Zirconia BlanksXT Stain/GlazeZirconia Dental Ceramics | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Shenzhen Xiangtong Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dongguan Xiangtong Co., Ltd. (2), Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Jun 2022 | K220017 | Coloring Liquid | Dongguan Xiangtong Co., Ltd. | EIH Porcelain Powder |
| 10 Dec 2020 | K202673 | X-cera Pre-shaded Zirconia Blanks | Dongguan Xiangtong Co., Ltd. | EIH Porcelain Powder |
| 29 Mar 2016 | K153767 | X-cera Zirconia Blanks | Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN XIANGTONG CO., LTD.FDA reg. 3013342350 | Shenzhen Guangdong, China | Foreign exporter |
| SHENZHEN XIANGTONG CO., LTD.FDA reg. 3018252381 | Dongguan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081760, 10088854). 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.