FDA Registration
Active
🇦🇺 Australia
IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)
Reg #: 3018501314
·
FEI: 3018501314
·
Expires 2026
Products
8
Proprietary Names
4
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)
- Registration Number
- 3018501314
- FEI Number
- 3018501314
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 759 - 767 Springvale Road
- City
- Mulgrave Victoria
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K212676
Owner / Operator
- Firm Name
- Osteon Medical
- Operator Number
- 10081414
- Address
- 759 - 767 Springvale Road
- City
- Mulgrave
- State
- Victoria
- Postal Code
- 3170
- Country
- AU
- Correspondent
- Farah Rahman
US Agent
- Business Name
- Implant Solutions Pty Ltd (Trading as Osteon Medical)
- Contact Name
- Farah Rahman
- Address
- Suite 150, 175 Technology Drive
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 866 9029272
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2022-10-12 |
| Restoration, Resin | NSM | Class N | Unknown | No | 2022-10-12 |
| Dentures, Full | NSL | Class N | Unknown | No | 2022-10-12 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-04-12 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2022-10-12 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-07-05 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2022-10-12 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2022-10-12 |
Proprietary Names
Osteon Prosthesis
Osteon Scan Gauge Kit
DESS Dental Smart Solutions
Osteon Precision Milled Suprastructure
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device