FDA Registration
Active
🇹🇼 Taiwan
Biodenta Dental Implant System
Reg #: 3017833095
·
FEI: 3017833095
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dentauspex Corporation
- Registration Number
- 3017833095
- FEI Number
- 3017833095
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.37, Sec. 3, Yunke Road
- City
- Douliu Yunlin
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K093630
Owner / Operator
- Firm Name
- Dentauspex Corporation
- Operator Number
- 10034185
- Address
- 1F., No. 37, Sec. 3, Yunke Rd
- City
- Douliu City
- State
- Yunlin
- Postal Code
- 640
- Country
- TW
- Correspondent
- Jeng-Tai Chen
US Agent
- Business Name
- Dynamic Biotech, Inc.
- Contact Name
- Feng-Yu Lee
- Address
- 29122 Rancho Viejo Rd., Suite 212
- City
- San Juan Capistrano
- State
- CA
- ZIP
- 92675
- Country
- US
- [email protected]
- Phone
- 949 2180929
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-11-12 |
Proprietary Names
Biodenta Dental Implant System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)