FDA Registration
Active
🇨🇳 China
Yongqing Huaguan Dental Instruments Factory
Reg #: 3014345250
·
FEI: 3014345250
·
Expires 2026
Products
9
Proprietary Names
13
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Yongqing Huaguan Dental Instruments Factory
- Registration Number
- 3014345250
- FEI Number
- 3014345250
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Intersection of Ronghua Road and Siwei Street, Yongqing Industrial Area
- City
- Langfang City Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233918
Owner / Operator
- Firm Name
- Yongqing Huaguan Dental Instruments Factory
- Operator Number
- 10057201
- Address
- Intersection of Ronghua Road and Siwei Street, Yongqing Industrial Area
- City
- Langfang City
- State
- Hebei
- Postal Code
- 065600
- Country
- CN
- Correspondent
- Ellis Hao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2021-06-21 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2022-05-10 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2019-01-28 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2024-05-12 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2021-06-21 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2021-06-21 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2018-03-13 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2019-01-08 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2018-03-06 |
Proprietary Names
Tray, impression ,Preformed
dental mixing well
Plastic Covers
Plastic Bags
Barrier Films
Dental Barrier and Sleeves
Evacuator, Oral Cavity
Mouthpiece, Saliva Ejector
Barrier Films, Plastic Covers, Plastic Bags
Poly Bibs
Poly Towels
Patient Bibs
Air/Water Syringe Tips
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device