Not currently registered with FDA under this name
Regeneration Technologies, Inc.
Alachua, FL, United States. Named as applicant on 1 dental 510(k) clearance between 2008 and 2008. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12008–2008
- Markets registered in
- 24 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Regeneration Technologies, 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 | Regeneration Technologies, Inc. | 1 clearances | 2008–2008 | Below |
| South Korea | MFDS | Manufacturer | Regeneration Technologies IncRegeneration Technologies inc. | 4 | 2006–2007 | 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 Regeneration Technologies, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Apr 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | NUN Human Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: RTI Surgical, Inc. (dba RTI Biologics, Inc.) (1), Young Innovations Inc (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.