Not currently registered with FDA under this name
Orthovita, Inc.
Malver, PA, United States. Named as applicant on 3 dental 510(k) clearances between 1995 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31995–2010
- Markets registered in
- 518 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Orthovita, 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 | Orthovita, Inc. | 3 clearances | 1995–2010 | Below |
| Taiwan | TFDA | Manufacturer | ORTHOVITA INC. | 7 | 2011–2018 | Pure Global AI |
| Canada | Health Canada | Registration holder | ORTHOVITA INC. | 6 | 1999–2007 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Orthovita, Inc. | 4 | 2001–2012 | Pure Global AI |
| Israel | AMAR | Manufacturer | ORTHOVITA | 1 | — | 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 Orthovita, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Sep 2010 | K091618 | VITOMATRIX | LYC Synthetic Bone Grafting Material |
| 19 Dec 1995 | K952922 | BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL | LYC Synthetic Bone Grafting Material |
| 10 Feb 1995 | K941780 | ORTHOVITA BIOGRAN | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: VB Spine, LLC (1).
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.