Manufacturer registered with FDA
Osteogenics Biomedical, Inc.
Lubbock, TX, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 16
- 510(k) clearances
- 51999–2021
- Markets registered in
- 15669 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 15 markets
Where regulators' registries name Osteogenics Biomedical, 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 | Osteogenics Biomedical, Inc. | 5 clearances | 1999–2021 | Below |
| European Union | EUDAMED | Manufacturer | Osteogenics Biomedical, Inc. | 461 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | OSTEOGENICS BIOMEDICAL, INC. | 91 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | OSTEOGENICS BIOMEDICAL, INC. | 22 | 2006–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Osteogenics Biomedical, INCOsteogenics Biomedical, Inc | 20 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Osteogenics Biomedical Inc | 17 | 2013–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Osteogenics Biomedical, Inc.OSTEOGENICS BIOMEDICAL, INC. · OSTEOGENICS BIOMEDICAL Inc. | 14 | 2013–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Osteogenics Biomedical, Inc. | 10 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Osteogenics Biomedical, Inc. | 9 | 2024–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSTEOGENICS BIOMEDICAL, INC.osteogenics biomedical, inc | 7 | 2013–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Osteogenics Biomedical, Inc. | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Osteogenics Biomedical IncOsteogenics Biomedical, Inc. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Osteogenics Biomedical, Inc.Osteogenics Biomedical,Inc | 4 | 2006–2009 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Osteogenics Biomedical, Inc. | 3 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OSTEOGENICS BIOMEDICAL, INC. | 1 | 2021–2021 | 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 Osteogenics Biomedical, 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 |
|---|---|---|---|---|
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | ZCORE EXPAND Expandable Collagen-Enriched Porcine XenograftZcore Porcine Xenograft ParticulateZCORE porcine xenograft particulate IN SYRINGE | 2015 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Osteo-Mesh TM-300 Titanium MeshRPM Reinforced PTFE Mesh | 2007 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Cytoplast GBR/TXT d-PTFE MembranesCytoplast Titanium-Reinforced PTFE Membranes | 2007 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | RPM Reinforced PTFE Mesh | 2018 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Cytoplast RTM Collagen MembraneSymbios Collagen MembraneVitala | 2016 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Pro-fix Bone Fixation ScrewsPro-fix Membrane Fixation ScrewsPro-fix Precision Fixation SystemPro-fix Tenting Screws | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Pro-fix Driver Handle | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Osteogenics Biomedical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jan 2021 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | NPK Intraoral Synthetic Barrier |
| 19 Oct 2017 | K171774 | RPM Reinforced PTFE Mesh | NPK Intraoral Synthetic Barrier |
| 1 Mar 2010 | K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | DZL Intraosseous Fixation Screw |
| 2 Mar 2000 | K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 | LYC Synthetic Bone Grafting Material |
| 4 Feb 1999 | K984230 | OSTEO-MESH TM-300 | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (1).
Also lists devices cleared under other names
Osteogenics Biomedical, 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 Matrix, Inc. (5), Osteogenics Co. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Apr 2021 | K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 11 Sep 2020 | K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 9 Feb 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 16 Jul 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 7 Aug 2001 | K011695 | COLLAGEN DENTAL MEMBRANE | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 6 Aug 1997 | K972278 | CYTOPLAST REGENTEX TITANIUM 250 | Osteogenics Co. | LYC Synthetic Bone Grafting Material |
| 11 Mar 1997 | K964342 | CYTOPLAST GBR | Osteogenics Co. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSTEOGENICS BIOMEDICAL, INC.FDA reg. 1650372 | LUBBOCK, TX, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9028315). 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.