Manufacturer registered with FDA
Osteon Medical
Mulgrave, Australia. Lists 2 dental device types with FDA across 2 registered establishments.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 321 registrations outside the US
- Establishments
- 2Australia, United States
Registered in 3 markets
Where regulators' registries name Osteon Medical as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Osteon Medical | 2 device types | — | Below |
| Australia | TGA | Registration holder | Implant Solutions Pty Ltd (trading as Osteon Medical) | 20 | 2013–2024 | Pure Global AI |
| Canada | Health Canada | Registration holder | IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL) | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Osteon Medical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DESS Dental Smart SolutionsOsteon Precision Milled Suprastructure | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Osteon Scan Gauge Kit | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Osteon Medical lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Terrats Medical, S.L. (5), Implant Solutions Pty Ltd (Aka Osteon Medical) (2), Implant Solutions Pty Ltd (Osteon Medical) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Apr 2024 | K240208 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 9 Mar 2024 | K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA Endosseous Dental Implant Abutment |
| 5 Jul 2022 | K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA Endosseous Dental Implant Abutment |
| 3 Mar 2022 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | NHA Endosseous Dental Implant Abutment |
| 4 Aug 2021 | K203464 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2018 | K173908 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)FDA reg. 3018501314 | Mulgrave Victoria, Australia | Foreign exporter, Manufacturer |
| IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL)FDA reg. 3023878501 | Irvine, CA, United States | Manufacturer |
Other names on FDA records
Implant Solutions Pty Ltd. (Trading AS Osteon Medical)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081414). 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.