Manufacturer registered with FDA
RTI Surgical, Inc. (dba RTI Biologics, Inc.)
Alachua, FL, United States. Lists 4 dental device types with FDA across 3 registered establishments.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1372 registrations outside the US
- Establishments
- 3Germany, United States
Registered in 13 markets
Where regulators' registries name RTI Surgical, Inc. (dba RTI Biologics, 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 | Manufacturer | RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 4 device types | — | Below |
| Canada | Health Canada | Registration holder | RTI SURGICAL, INC., DBA RTI BIOLOGICS, INC.TUTOGEN MEDICAL GMBH | 40 | 1999–2010 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tutogen Medical GmbH | 8 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TUTOGEN MEDICAL GMBH | 7 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Tutogen Medical GmbH | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Tutogen Medical GmbHTutogen Medical GmBH | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RTI SURGICAL, Inc (dba RTI BIOLOGICS, Inc.) | 2 | 2022–2022 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Tutogen Medical GmbH | 2 | 2024–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TUTOGEN Medical GmbH | 2 | 2004–2004 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Tutogen Medical GmbH | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Tutogen Medical GmbH | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Tutogen Medical GmbH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Tutogen Medical GmbH | 1 | 2014–2014 | 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
Devices listed with FDA
What RTI Surgical, Inc. (dba RTI Biologics, Inc.) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | CopiOs® Pericardium MembraneTutodent® membrane | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | component of dbm product | 2008 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | — | 2026 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | AlloSculpt-3D PlusRegenafilRegenaformRegenavate | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
RTI Surgical, Inc. (dba RTI Biologics, Inc.) lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Collagen Solutions, LLC (1), Tutogen Medical U.S., Inc. (1), Regeneration Technologies, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Aug 2024 | K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | NPM Animal Source Bone Grafting Material |
| 12 May 2008 | K073097 | TUTODENT DENTAL MEMBRANE | Tutogen Medical U.S., Inc. | NPL Intraoral Animal Source Barrier |
| 30 Apr 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. | NUN Human Source Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COLLAGEN SOLUTIONS/TISSX LLC d/b/a EvergenFDA reg. 3014003617 | Eden Prairie, MN, United States | Specification developer |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.)FDA reg. 3002719998 | ALACHUA, FL, United States | Manufacturer, Repacker / relabeler, Specification developer |
| Tutogen Medical GmBHFDA reg. 3002924436 | Neunkirchen am Brand Bavaria, Germany | Manufacturer |
Other names on FDA records
Tutogen Medical GmbH · COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1641375). 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.