Not currently registered with FDA under this name
Implant Solutions Pty Ltd (Aka Osteon Medical)
Mulgrave, Australia. Named as applicant on 2 dental 510(k) clearances between 2022 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22022–2024
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Implant Solutions Pty Ltd (Aka Osteon Medical) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Mar 2024 | K233083 | Osteon Precision Milled Suprastructure | NHA Endosseous Dental Implant Abutment |
| 5 Jul 2022 | K221019 | Osteon Precision Milled Suprastructure | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Osteon Medical (2).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.