FDA Registration
Active
🇺🇸 United States
IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)
Reg #: 3023878501
·
FEI: 3023878501
·
Expires 2026
Products
7
Proprietary Names
2
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)
- Registration Number
- 3023878501
- FEI Number
- 3023878501
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- Suite 150, 175 Technology Drive
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233083
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-09-03 |
| Dentures, Full | NSL | Class N | Unknown | No | 2022-10-12 |
| Restoration, Resin | NSM | Class N | Unknown | No | 2022-10-12 |
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2022-10-12 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2022-10-12 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2022-10-12 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2022-10-12 |
Proprietary Names
Osteon Precision Milled Suprastructure
Osteon Prosthesis
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device