FDA Registration
Active
🇿🇦 South Africa
Implant, Endosseous, Root-Form - Zygomatic Implants
Reg #: 3003394627
·
FEI: 3003394627
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SOUTHERN IMPLANTS (PTY) LTD
- Registration Number
- 3003394627
- FEI Number
- 3003394627
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ONE ALBERT ROAD
- City
- IRENE Gauteng
- Country
- ZA
Regulatory Submissions
- 510(k) Number
- K093562
Owner / Operator
- Firm Name
- SOUTHERN IMPLANTS (PTY) LTD
- Operator Number
- 9073913
- Address
- ONE ALBERT ROAD, --
- City
- IRENE, GAUTENG
- State
- ZA-NOTA
- Postal Code
- 0062
- Country
- ZA
US Agent
- Business Name
- SOUTHERN IMPLANTS NORTH AMERICA Inc.
- Contact Name
- David Luiz
- Address
- 225 Chimney Corner Lane, Suite 3011
- City
- Jupiter
- State
- FL
- ZIP
- 33458
- Country
- US
- [email protected]
- Phone
- 561 4720991
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-01-30 |
Proprietary Names
Implant, Endosseous, Root-Form - Zygomatic Implants
Establishment Types
Manufacture Medical Device