Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017619674

FEI Number

3017619674

Entity Name

FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Foshan Guangdong, CN

Establishment Address

Block A, Sanyi logistics zone, Luocun, Foshan Guangdong 528226, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Foshan Wenjian Medical Instrument Co., Ltd. (Owner Number: 10078430)

Owner / Operator Contact Address

Block A, Sanyi logistics zone, Luocun, Foshan, Guangdong, China, Foshan, CN-GD 528226, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181691

PMA Number

N/A

All Registered Proprietary Names

High-speed air turbine handpiece (model: WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134, WJ -132, WJ - 144) Low-speed air turbine handpiece (WJ-414, WJ-412, WJ-424, WJ-422) High-speed air turbine handpiece (model: WJ-142, WJ-154, WJ-152, WJ-164, WJ-162)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2020-10-22
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2020-10-22

Official Correspondent

Lijian YU

US Agent Details

William Yang Business: CCIC Chicago Inc. Email: fda@ccicchicago.com Phone: (630) 7181762

Related Public Records

Same Entity

Foshan Wenjian Medical Instrument 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
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017619674. Last updated year: 2026. Please use registration number 3017619674 when referencing this establishment in official correspondence.