FDA Registration
Active
🇨🇳 China
DONGGUAN WANJIN INDUSTRIAL CO., LTD
Reg #: 3010656982
·
FEI: 3010656982
·
Expires 2026
Products
41
Proprietary Names
35
Establishment Types
3
Classifications
41
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Registration Details
- Registration Name
- DONGGUAN WANJIN INDUSTRIAL CO., LTD
- Registration Number
- 3010656982
- FEI Number
- 3010656982
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SongBoTang Area, ChangPing
- City
- DongGuang Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K183263
Owner / Operator
- Firm Name
- Dongguan Wanjin Industrial Co., Ltd
- Operator Number
- 10045813
- Address
- SongBoTang Area, ChangPing
- City
- DongGuang
- State
- Guangdong
- Postal Code
- 523561
- Country
- CN
- Correspondent
- Luling Wang
US Agent
- Business Name
- PacStar International, Inc.
- Contact Name
- Frank Fu
- Address
- 2650 Myrtle Ave., Unit B1, Unit B1
- City
- Monrovia
- State
- CA
- ZIP
- 91016
- Country
- US
- [email protected]
- Phone
- 626 8980055
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2018-06-04 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2021-07-19 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2015-09-25 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2015-06-23 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2019-01-19 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-04-18 |
| Oil, Clearing | IJZ | Class 1 | Pathology | No | 2015-09-25 |
| Pouch, Colostomy | EZQ | Class 1 | Gastroenterology, Urology | No | 2017-12-01 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2018-09-24 |
| Holder, Radiographic Cassette, Wall-Mounted | IXY | Class 1 | Radiology | No | 2015-09-25 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2018-06-04 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2019-01-19 |
| Tube Mount, X-Ray, Diagnostic | IYB | Class 1 | Radiology | No | 2015-06-23 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2017-12-01 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2019-07-14 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2018-09-24 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2023-06-24 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2015-06-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-21 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2018-09-23 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2013-12-31 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2015-09-25 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2017-12-01 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2018-09-24 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2018-09-24 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2014-05-30 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2015-09-25 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2018-09-24 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 2018-06-04 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2015-09-25 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2019-07-23 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | PTX | Class 2 | General, Plastic Surgery | No | 2017-12-01 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2019-01-19 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2018-03-30 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2015-09-25 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2021-02-24 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2018-03-30 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2015-06-22 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2015-09-25 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2018-09-24 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2019-01-19 |
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
Optic Light
Air Water Syringe
Evacuator Tips
sutrue
Eyewear
Mask
Irrigation Syringe
Cover Gowns
Reamer Endodontic
Saliva Ejector
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Remanufacture Medical Device