Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021386681

FEI Number

3021386681

Entity Name

DONGGUAN OUWEN MEDICAL DEVICE TECHNOLOGY CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 301, Building 2, No.8 Shuxin Gongling Second Road, Changping Town, Dongguan Guangdong 523560, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan Ouwen Medical Device Technology Co., Ltd. (Owner Number: 10083767)

Owner / Operator Contact Address

Room 301, Building 2, No.8 Shuxin Gongling Second Road, Changping Town, Dongguan, CN-GD 523560, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Air-Water Syringe Tips Disposable Mixing Disc Dental Prosthesis Adhesive Stick; Disposable Dental Microapplicator Prophy Cup; Prophy Brush SALIVA EJECTOR Dental Conveyor Dental Composite Extruder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2021-12-17
JRO	Blender/Mixer	Clinical Chemistry	Class 1	862.2050	2023-11-12
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-12-17
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2021-12-17
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2025-03-09
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2021-12-17

Official Correspondent

Jianwei Hou

US Agent Details

Sam Shi Business: Medwin Inc. Email: MedwinInc@Aliyun.Com Phone: (626) 2651595

Related Public Records

Same Entity

Dongguan Ouwen Medical Device 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Similar Registrations

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3010057414	LUZZANI DENTAL SRL	Senago Milano, IT
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3035858919	YUEYING MEDICAL INSTRUMENTS (LANGFANG) CO., LTD.	Langfang City Hebei, CN
3010741366	INTERSURGICAL S.P.A.	Mirandola (MO) Italy Modena, IT
3021023132	WUXI LYUSMILE IMP AND EXP CO.,LTD	WUXI Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021386681. Last updated year: 2026. Please use registration number 3021386681 when referencing this establishment in official correspondence.