FDA Registration
Active
🇨🇳 China
Pre-Finisher
Reg #: 3005537733
·
FEI: 3005537733
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WUXI TP ORTHODONTICS MATERIAL CO., LTD.
- Registration Number
- 3005537733
- FEI Number
- 3005537733
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- L2, A2 BUILDING, LIYUAN ECONOMIC DEVELOPMENT ZONE
- City
- WUXI Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K780619
Owner / Operator
- Firm Name
- TP ORTHODONTICS, INC.
- Operator Number
- 1815540
- Address
- 100 CENTER PLAZA, --
- City
- La Porte
- State
- IN
- Postal Code
- 46350
- Country
- US
US Agent
- Business Name
- TP Orthodontics
- Contact Name
- Cristiane Muller
- Address
- 100 Center Plaza
- City
- La Porte
- State
- IN
- ZIP
- 46350
- Country
- US
- [email protected]
- Phone
- 219 7852591
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2008-12-08 |
Proprietary Names
Pre-Finisher
Custom tooth positioner
Custom retainer
Pre-finisher appliance with seating spring
Establishment Types
Manufacture Medical Device