FDA Registration
Active
🇨🇳 China
UNITED DENTAL CHANGZHOU
Reg #: 3015526995
·
FEI: 3015526995
·
Expires 2026
Products
12
Proprietary Names
11
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- UNITED DENTAL CHANGZHOU
- Registration Number
- 3015526995
- FEI Number
- 3015526995
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- United Dental Changzhou
- Operator Number
- 10062136
- Address
- B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213145
- Country
- CN
- Correspondent
- Yue Wu
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 |
|---|---|---|---|---|---|
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2019-12-22 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2019-12-23 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2020-01-18 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2019-12-22 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2019-12-22 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2020-01-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-01-18 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2019-12-23 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2019-12-22 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2020-01-18 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2019-12-23 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2019-12-23 |
Proprietary Names
Orthodontic metal Brackets, Orthodontic metal self ligating Brackets
Irrigation needles
Orthodontic Expansion Screws
Orthodontic Stainless steel Wires, Orthodontic Niti Wires
Rotary files/Root canal files, Hand use files/Manual files, Sterile Root Canal Files
Bondent Instrument Retrieval Kit
Plugger
Crimple hooks, Crimple hooks
Rotary files/Root canal files, Hand use files/Manual files, Sterile Endodontic Hand Instruments
Paper points
Gutta percha points
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device