Not currently registered with FDA under this name
Osseofuse, Inc.
Fullerton, CA, United States. Named as applicant on 2 dental 510(k) clearances between 2013 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22013–2014
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Osseofuse, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Osseofuse, Inc. | 2 clearances | 2013–2014 | Below |
| Taiwan | TFDA | Manufacturer | OSSEOFUSE INC. | 2 | 2015–2022 | 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
510(k) clearances
Clearances on which FDA names Osseofuse, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Sep 2014 | K133050 | ONE PLUS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 31 Oct 2013 | K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Osseofuse International Inc. (2), KJ Meditech Co., Ltd. (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.