Not currently registered with FDA under this name
Usbiomaterials Corp.
Alachua, FL, United States. Named as applicant on 5 dental 510(k) clearances between 1993 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 51993–2003
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Usbiomaterials 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 | Usbiomaterials Corp. | 5 clearances | 1993–2003 | Below |
| South Korea | MFDS | Manufacturer | USBiomaterials Corporation | 1 | 2002–2002 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | US BIOMATERIALS CORPORATION | 1 | 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 Usbiomaterials Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Jul 2003 | K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | EJR Oral Cavity Abrasive Polishing Agent |
| 7 Feb 2000 | K000149 | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE | LYC Synthetic Bone Grafting Material |
| 15 Oct 1999 | K992416 | PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE | LYC Synthetic Bone Grafting Material |
| 20 Sep 1996 | K962494 | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE | LYC Synthetic Bone Grafting Material |
| 4 Nov 1993 | K930115 | PERIOGLASS | LYC Synthetic Bone Grafting Material |
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.