Manufacturer registered with FDA
Shenzhen Xpectvision Technology Co., Ltd.
Shenzhen, China. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 22022–2024
- Markets registered in
- 815 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Shenzhen Xpectvision 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 | Shenzhen Xpectvision Technology Co., Ltd. | 2 clearances | 2022–2024 | Below |
| Colombia | INVIMA | Manufacturer | SHENZHEN XPECTVISION TECHNOLOGY CO., LTD. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN XPECTVISION TECHNOLOGY CO., LTD. | 3 | 2023–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN XPECTVISION TECHNOLOGY CO.,LTD | 2 | 2023–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SHENZHEN XPECTVISION TECHNOLOGY CO; LTD. | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shenzhen Xpectvision Technology Co., Ltd. | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shenzhen Xpectvision Technology Co., Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shenzhen XpectVision 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 Shenzhen Xpectvision 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 |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Intraoral X-ray Sensor Holder, Model XVH001 | 2022 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | XpectVision, Handheld Dental X-ray System, XVbeam2000 | 2024 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | XVD2121 PlusXVD2530 | 2022 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | Sensor sheath, Model XVC001, XVC002, XVC003, XVC004 | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Shenzhen Xpectvision Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Feb 2024 | K233914 | XVbeam2000 | EHD Extraoral with Timer X-Ray Unit |
| 17 Feb 2022 | K220277 | Digital Intraoral X-ray Sensor | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: CAO Group, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.FDA reg. 3022107311 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084490). 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.