Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022107311

FEI Number

3022107311

Entity Name

SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1st Floor, Building A31, No.44 Xiangrui 3rd Road, Nanshan District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shenzhen Xpectvision Technology Co., Ltd. (Owner Number: 10084490)

Owner / Operator Contact Address

B507, Block A and B, Nanshan Medical Device Industrial Park, Nanhai Avenue 1019, Nanshan District, Shenzhen, CN-GD 518067, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sensor sheath, Model XVC001, XVC002, XVC003, XVC004 XpectVision, Handheld Dental X-ray System, XVbeam2000 Intraoral X-ray Sensor Holder, Model XVH001

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2022-10-30
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-02-20
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2022-10-30

Official Correspondent

Silver Cai

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Shenzhen Xpectvision Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
3039246551	SUMMIT DENTAL SYSTEMS LLC.	Fort Lauderdale, FL, US
3038285060	GREATCARE 4U SDN BHD	Selangor Darul Ehsan, MY
3025414363	TIANJIN WATER SOURCE TECH CO., LTD.	Tianjin, CN
3017604	ASEPTICO, INC.	WOODINVILLE, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022107311. Last updated year: 2026. Please use registration number 3022107311 when referencing this establishment in official correspondence.