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Sign in to claim this brandIMPLANT SOLUTIONS PTY LTD
US
Last updated May 30, 2026
What IMPLANT SOLUTIONS PTY LTD makes
The company manufactures dental implant components, including single-use intraoral-scanning abutment analogs, as well as custom-made temporary and permanent suprastructures for dental implants. These products are designed to support intraoral scanning processes and provide restorative solutions for patients requiring dental prosthetics.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with some products falling under exemptions (Class N). These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Implant Solutions Pty Ltd manufacture?
Implant Solutions Pty Ltd specializes in dental implant components. Their portfolio includes single-use intraoral-scanning abutment analogs, which assist in digital scanning for dental restorations, as well as custom-made temporary and permanent suprastructures for dental implants. These devices are designed to support the fabrication of dental prosthetics and improve patient outcomes in restorative dentistry.
Where is Implant Solutions Pty Ltd based?
The company is based in the United States. This location aligns with its focus on manufacturing and distributing dental implant devices that comply with U.S. regulatory standards, including those listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list Implant Solutions Pty Ltd’s devices?
Implant Solutions Pty Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for dental implant components, including single-use scanning analogs and custom-made suprastructures, by assigning unique identifiers to each product.
How are Implant Solutions Pty Ltd’s devices classified under regulatory frameworks?
The company’s devices fall into different regulatory classifications: most are classified as Class I or Class II, which require varying levels of premarket review depending on risk. Some products are also classified as Class N, meaning they are exempt from certain regulatory controls due to their low risk or routine use in dental procedures. Classification depends on factors like the device’s purpose, complexity, and potential patient risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- osteonmedical.com
- —
- —
- [email protected]
- Phone
- +61392640111
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 756242111
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Osteon Medical | 1 | FDA UDI | Class II | Active |
| Osteon Medical | 1 | FDA UDI | Class II | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class II | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class II | Active |
| Osteon Medical | 1 | FDA UDI | N | Active |
| Osteon Medical | 1 | FDA UDI | Class I | Active |
| Osteon Medical | 1 | FDA UDI | Class II | Active |
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