FUSSEN TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3018999255

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018999255
FEI Number
3018999255
Entity Name
FUSSEN TECHNOLOGY CO., LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District, Shenzhen Guangdong 518055, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fussen Technology Co., Ltd (Owner Number: 10081508)
Owner / Operator Contact Address
901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue, Changyuan Community, Taoyuan Street, Nanshan District, Shenzhen, CN-GD 518055, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192766
PMA Number
N/A

All Registered Proprietary Names

Fussen, Digital Intraoral Scanner System S6000 Fussen, Digital Intraoral Scanner System S6500 Fussen, Digital Intraoral Scanner System S7000 S7000 Premium Fussen,Digital Intraoral Scanner System S10 Digital Intraoral Imaging Plate System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2021-04-21
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2024-09-05

Official Correspondent

registration registration

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Fussen 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
K221008 Shanghai Handy Medical Equipment Co., Ltd. HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) 2022-06-22
K160788 Ray Co., Ltd. RIOScan (RPS500) 2016-04-15

Similar Registrations

Registration Number Establishment Name Location
3045007778 CMEOS MEDICAL SCI & TECH (WUXI) CO., LTD. Wuxi Jiangsu, CN
3015786035 TUPEL LTD Oxford Oxfordshire, GB
3035512103 SHENZHEN SHUHE TECHNOLOGY CO., LTD Shenzhen Guangdong, CN
3044905014 FUSSEN IMAGING CO.,LTD. Shenzhen Guangdong, CN
3010158379 DOF INC Seoul, KR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018999255. Last updated year: 2026. Please use registration number 3018999255 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.