Not currently registered with FDA under this name
Osteo Implant Corp.
New Castle, PA, United States. Named as applicant on 2 dental 510(k) clearances between 1987 and 1995. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21987–1995
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Osteo Implant Corp. 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 | Osteo Implant Corp. | 2 clearances | 1987–1995 | Below |
| South Korea | MFDS | Manufacturer | Osteo Implant Corporation | 2 | 2001–2001 | 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 Osteo Implant Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Jul 1995 | K945706 | BONE DRILL | DZE Root-Form Endosseous Implant |
| 10 Feb 1987 | K862854 | OSTEO TITANIUM DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: American Dental Implant Corporation (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.