Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010656982

FEI Number

3010656982

Entity Name

DONGGUAN WANJIN INDUSTRIAL CO., LTD

City/State/Country

DongGuang Guangdong, CN

Establishment Address

SongBoTang Area, ChangPing, DongGuang Guangdong 523561, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Dongguan Wanjin Industrial Co., Ltd (Owner Number: 10045813)

Owner / Operator Contact Address

SongBoTang Area, ChangPing, DongGuang, CN-GD 523561, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endo Motor Head Rest Covers Bracket Tray Covers Cotton Roll Face Sheilds B&B Cleaning Oil pouch File Film Holder Low Speed Motor X Ray Film Mount cleaner Plastic Teeth Model Tube Impression Gauze patient bib Face mask (general controls) Resin Denture Tooth Dental Light blade Burs CUP X Ray Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2018-06-04
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-07-19
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2015-09-25
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2015-06-23
EFN	Cotton, Roll	Dental	Class 1	872.6050	2019-01-19
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-18
IJZ	Oil, Clearing	Pathology	Class 1	864.4010	2015-09-25
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2017-12-01
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2018-09-24
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	2015-09-25
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2018-06-04
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2019-01-19
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2015-06-23
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2017-12-01
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2019-07-14
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2018-09-24
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-06-24
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2015-06-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-21
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2018-09-23
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2013-12-31
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2015-09-25
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2017-12-01
EJL	Bur, Dental	Dental	Class 1	872.3240	2018-09-24
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2018-09-24
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2014-05-30
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2015-09-25
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2018-09-24

Official Correspondent

Luling Wang

US Agent Details

Frank Fu Business: PacStar International, Inc. Email: pacstardental@gmail.com Phone: (626) 8980055

Related Public Records

Same Entity

Dongguan Wanjin Industrial 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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

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3034246209	Baz Biomedic Co., Ltd.	Seoul, KR
3012447612	Highridge Medical, LLC	Westminster, CO, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
3013493300	Devroye Instruments SRL	Etterbeek Brussels-Capital Region, BE
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010656982. Last updated year: 2026. Please use registration number 3010656982 when referencing this establishment in official correspondence.