Bone grafts & membranes: manufacturers and brands
81 companies make or specify dental bone grafts among the 112 that list one with FDA, under 532 brand and model names. FDA has issued 377 510(k) clearances in this category, 37 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental bone graft manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | Straumann BoneCeramic · MembraGel · Synthetic Barrier, intraoral · Straumann Membrane Max · +1 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Ossix Agile · Ossix Breeze · OSSIX Plus · OSSIX VOLUMAX · +3 | 148 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | A-Graft | 68 | 2026 |
| Geistlich Pharma AG | Switzerland | Maker | Combi-Kit Collagen · Geistlich Bio-Gide® · Geistlich Bio-Gide® Compressed · Geistlich Bio-Gide® Forte · +10 | 30 | 2025 |
| GC America Inc. | United States | Maker | Cytrans Elashield · Cytrans Granules · Foundation | 137 | 2026 |
| Hiossen Inc. | United States | Maker | A-Graft | 26 | 2026 |
| Cowellmedi Co., Ltd. | South Korea | Maker | InnoGenic Non-resorbable Membrane | 14 | 2025 |
| GENOSS Co., Ltd. | South Korea | Maker | DT7B0320 · DT7B0420 · DT7B0440 · DT7B0510 · +128 | 23 | 2025 |
| Meta Biomed Co, Ltd | United States | Maker | BoneMedik-DM · Renew-Cera | 24 | 2024 |
| Young Innovations Inc | United States | Maker | AmpliDerm · AMPLIFI Long Term Membrane · OraMEM® Plus Resorbable Collagen Membrane · Renovix · +8 | 23 | 2025 |
| Keystone Dental Inc. | United States | Maker | Accell Connexus · DynaGraft · ORTHOBLAST II PASTE · PUTTY · +2 | 7 | 2024 |
| PURGO BIOLOGICS Inc. | South Korea | Maker | THE Graft · THE Graft Collagen · CYTOSHIELD · OpenTex · +2 | 5 | 2024 |
| SigmaGraft, Inc. | United States | Maker | InterOss · InterOss Collagen · Maxxeus · Maxxeus Dental Xenograft Particulates · +2 | 3 | 2023 |
| MEDPARK.Co., Ltd. | South Korea | Maker | Endobon® Bovine Xenograft Moldable · Endobon® Bovine Xenograft Particulate | 2 | 2026 |
| Collagen Matrix, Inc. | United States | Maker | MatrixDerm CAP Regenerative Collagen Dental Membrane · MatrixDerm EXT Regenerative Collagen Dental Membrane · MatrixDerm Regenerative Collagen Dental Membrane · Matrixflex · +15 | 20 | 2024 |
| Beijing Naton Technology Group Co. Ltd. | China | Maker | Inion BioRestore Synthetic Bone Graft Substitute · Inion GTR Accessory Instrument · Inion GTR Biodegradable Membrane System | 10 | 2025 |
| Neoss AB | Sweden | Maker | NeoGen Collagen Firm · NeoGen Collagen Flex | 10 | 2022 |
| Wishbone | Belgium | Maker | W-Bone · Wishbone HA · Wishbone HAE | 2 | 2026 |
| ZimVie US Corp LLC | United States | Maker | RegenerOss Allograft Putty · RegenerOss Allograft Putty Plus Mineralized | 1 | 2026 |
| HYUNDAI BIOLAND Co., Ltd. | South Korea | Maker | Oradapt · OsseoSeal · OssGuide · OsteoFlex · +3 | 1 | 2026 |
| Aroa Biosurgery Ltd | New Zealand | Maker | Aroa Dental Membrane · Endoform Dental Membrane | 1 | 2024 |
| botiss biomaterials GmbH | Germany | Maker | Jason membrane · Straumann Jason membrane · cerabone · Straumann cerabone | 1 | 2025 |
| Beijing Biosis Healing Biological Technology Co., Ltd | China | Maker | Oral Matrix | 1 | 2024 |
| Bonalive Ltd | Finland | Maker | Bonalive Maxillofacial | 1 | 2026 |
| Hudens Bio Co., Ltd. | South Korea | Maker | BONTREE PLUS | 1 | 2026 |
| Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | China | Maker | Neocirrus Augmented Gingival Matrix | 1 | 2025 |
| Osteogene Tech Inc. | United States | Maker | InRoad Synthetic Bone Graft | 1 | 2022 |
| Bicon, LLC | United States | Maker | SynthoGraft | 18 | 2015 |
| Septodont | France | Maker | — | 17 | 2021 |
| Zimmer Inc | United States | Maker | ENDOBON XENOGRAFT GRANULES | 14 | 2001 |
| Medtronic, Inc. | United States | Maker | Mastergraft Mini Granules · MASTERGRAFT PUTTY · Grafton DBM · Grafton DBM Paste · +2 | 11 | 2014 |
| Impladent , Ltd. | United States | Maker | OsteoGen · OsteoTape / OsteoGen Plug / OsteoGen Strip | 10 | 2014 |
| Novabone Products, LLC | United States | Maker | Bioactive Synthetic Bone Graft Dental Morsels · Bioactive Synthetic Bone Graft Dental Putty Cartridges · Cartridge Dispenser · NovaBone Cartridge Applicator Gun · +3 | 9 | 2011 |
| Unicare Biomedical, Inc. | United States | Maker | Cytoflex Resorb · Cytoflex Tefguard · Unigraft · Cytoflex Ti-Enforced Membrane · +2 | 9 | 2015 |
| SYNTHES (USA) Products LLC | United States | Maker | bone grafting material · chronOS - ß-TCP - LPK | 7 | 2020 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | bone grafting material | 5 | 2013 |
| Osteogenics Biomedical, Inc. | United States | Maker | ZCORE EXPAND Expandable Collagen-Enriched Porcine Xenograft · Zcore Porcine Xenograft Particulate · ZCORE porcine xenograft particulate IN SYRINGE · Cytoplast GBR/TXT d-PTFE Membranes · +5 | 5 | 2021 |
| curasan AG | Germany | Maker | Ceracell Dental · CERASORB Bioactive · Cerasorb Dental · IngeniOs Beta-TCP Bioactive · +3 | 5 | 2012 |
| NIBEC Co Ltd | South Korea | Maker | bone grafting material, animal source · Creos Xenogain · Creos Xenogain Collagen · Instradent Xenograft · +10 | 4 | 2015 |
| Baxter Healthcare Corp | United States | Maker | Actifuse | 4 | 2009 |
| Odontit S.A. | Argentina | Maker | CevOss · CITAGENIX · Kalos Biomedical · Osseo Seal · +1 | 3 | 2014 |
| Cook Biotech Incorporated | United States | Maker | DynaMatrix · DynaMatrix Plus · DynaMatrix Plus Extracellular Membrane | 3 | 2017 |
| Integra LifeSciences Corporation | United States | Maker | BioMend Absorbable Collagen Membrane · Biomend Extend Absorbable Collagen Membrane · HeliMend Absorbable Collagen Membrane · HeliMend Advanced Absorbable Collagen Membrane · +2 | 2 | 2014 |
| DePuy Spine, Inc. | United States | Maker | HEALOS Dental · HEALOS Dental Bone Graft Replacement · Healos II Bone Graft Substitute · Symphony · +1 | 2 | 2010 |
| SeaSpine Orthopedics Corporation | United States | Maker | Accell Connexus Keystone Dental · DynaBlast Paste · DynaBlast Putty · DynaGraft D Gel · +3 | 2 | 2005 |
| Augma Biomaterials | Israel | Maker | Bond Apatite · 3D Bond · 3D Bond+ | 2 | 2013 |
| Musculoskeletal Transplant Foundation | United States | Maker | DBX Dental | 2 | 2009 |
| Cytophil, Inc | United States | Maker | — | 2 | 2010 |
| Teknimed | France | Maker | — | 2 | 2009 |
| Dsm Biomedical | United States | Maker | DSM Biomedical Porcine Pericardium Dental Membrane · Meso Dental Membrane · Epi-Guide Bioresorb Barrier Matrix · DSM Dental Bone Graft · +1 | 1 | 2020 |
| Matricel GmbH | Germany | Maker | creos xenoprotect · Kontour Matrix · Zmatrix | 1 | 2014 |
| Ceramisys Ltd | United Kingdom | Maker | ReproBone¿ Synthetic · Resorbable Bone Graft Substitute | 1 | 2011 |
| Exactech, Inc. | United States | Maker | Optecure Dental · Optecure Dental +CCC | 1 | 2011 |
| Hans Biomed Corp. | South Korea | Maker | ExFuse(tm) II Putty · SurFuse(tm) II Putty | 1 | 2014 |
| Orthocell Limited | Australia | Maker | perFORM · Striate+ | 1 | 2021 |
| Chiyewon Co., Ltd. | South Korea | Maker | — | 1 | 2015 |
| Sotera Health LLC | United States | Maker | Actifuse Shape (size 1-2mm/contents 1.6 mL) · Actifuse Shape (size 1-2mm/contents 15.8 mL) · Actifuse Shape (size 1-2mm/contents 2.6 mL) · Actifuse Shape (size 1-2mm/contents 8 mL) · +48 | — | — |
| STERIS Corporation | United States | Maker | ATRISORB®-D Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline · BiconDental1716 (NR) - SynthoGraft · MedtronicSofamore (AH) - BIPHASIC CALCIUM BO · Osteogene8842 (WH) - InRoad Dental Synthetic Bone Graft · +1 | — | — |
| BBF Sterilisationsservice GmbH | Germany | Maker | Ceracell DENTAL · IngeniOs ß-TCP Bioactive · Osseolive DENTAL · CopiOs Paricardium Membrane · +2 | — | — |
| Life Science Outsourcing, Inc. | United States | Maker | — | — | — |
| DePuy Synthes, Inc. | United States | Maker | Symphony | — | — |
| Advanced Medical Solutions Group PLC | United Kingdom | Maker | ECLIPSE · ECLIPSE Putty · In'Oss · MBCP · +6 | — | — |
| Millstone Medical Outsourcing LLC | United States | Maker | RegenerOss | — | — |
| UFP Technologies, Inc. | United States | Maker | SYNTHOGRAFT | — | — |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | United States | Maker | CopiOs® Pericardium Membrane · Tutodent® membrane · AlloSculpt-3D Plus · Regenafil · +2 | — | — |
| Steiner Biotechnology LLC | United States | Maker | OsseoConduct · Sinus Graft · Socket Graft | — | — |
| biotrics bioimplants AG | Germany | Maker | Jason membrane · Straumann Jason membrane | — | — |
| AbbVie, Inc. | United States | Maker | NovoMatrix Reconstructive Tissue Matrix | — | — |
| Armm, Inc. | United States | Maker | — | — | — |
| CG Bio Co., Ltd. | South Korea | Maker | Bongros | — | — |
| Criteria Industria e Comercio de Produtos Medicinais e Odont | Brazil | Maker | Lumina-PTFE Titanium | — | — |
| GFS Chemicals, Inc. | United States | Maker | Beta Tricalcium Phosphate | — | — |
| Globus Medical Inc | United States | Maker | Harvest SmartJet | — | — |
| Maxigen Biotech Inc | Taiwan | Maker | bone grafting material, animal source | — | — |
| Medos International SARL | United States | Maker | SYMPHONY - GDS | — | — |
| VB Spine, LLC | United States | Maker | VITOMATRIX BONE GRAFTING MATERIAL | — | — |
| 韩国速压科技有限公司SOYAGREENTEC Co.,Ltd. | South Korea | Maker | OSTEON | — | — |
| Arctic Biomaterials Oy | Finland | Maker | — | — | — |
| Cam Bioceramics | Netherlands | Maker | — | — | — |
| Highridge Medical, LLC | United States | Maker | — | — | — |
| Wesley Coe (Cambridge) Ltd. | United Kingdom | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | — | 56 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | creos | 94 | 2026 |
| Stryker | United States | Contract manufacturer | MEDPOR CONTAIN CAN Implant · MEDPOR CONTAIN Implant | 33 | 2024 |
| Park Dental Research Corp | United States | Contract manufacturer | StarGraft Granules · StarGraft Putty · StarDerm · StarMem | 8 | 2026 |
| J. Morita USA, Inc. | United States | Foreign exporter | Foundation | 42 | 2022 |
| Bausch & Lomb Incorporated | United States | Manufacturer | — | 3 | 1994 |
| Ritter Implants GmbH and Co. KG | United States | Manufacturer | Oral Matrix | 2 | 2019 |
| Olympus Corporation | Japan | Foreign exporter | Kartush Hydroxlapatite Disks · Porous Hydroxlapatite granules | 1 | 2007 |
| Sweden & Martina INC | United States | Lister | COLLAGEN DENTAL MEMBRANE · NEOMEM ECM · NEOMEM FLEX PLUS · OSSIX PLUS · +7 | — | — |
| TBS Dental | United States | Repacker / relabeler | PTFE Membrane | — | — |
| IDOC Dental Lab | United States | Contract manufacturer | BONE GRAFTING MATERIAL, ANIMAL SOURCE | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | CevOss · PreservaRidge · The Graft · The Graft Collagen · +10 | — | — |
| Epione Bidco | France | Contract sterilizer | RESORBA Synthetic Bone · Bionnovation Oss XB · W-Bone · Wishbone HA | — | — |
| Midwest Sterilization Corp. | United States | Contract sterilizer | Kartush hydroxylapatite disk 10mm · Kartush hydroxylapatite disk 14mm · Kartush hydroxylapatite disk 20mm · Kartush hydroxylapatite disk 7mm · +4 | — | — |
| Greenpia Technology Inc. | South Korea | Contract sterilizer | OssGuide | — | — |
| Mediplast Israel Ltd. | Israel | Contract sterilizer | OSSIX Breeze · OSSIX® PLUS · OSSIX® VOLUMAX · OSSIX Bone | — | — |
| Hudson Scientific LLC | United States | Repacker / relabeler | OSSIX PLUS · OSSIX VOLUMAX · OSSIX BONE | — | — |
| Rose GmbH fuer Medizintechnik | Germany | Contract sterilizer | Jason membrane · Jason® membrane / Straumann® Jason® membrane · Straumann Jason membrane | — | — |
| HA2 Medizintechnik GmbH | Germany | Contract sterilizer | Creos xenoprotect, Kontour Matrix, Zmatrix | — | — |
| Steritec Services LLC | United States | Contract sterilizer | dental bone plate | — | — |
| Steritech | Australia | Contract sterilizer | perFORM, MODEL perf1520, perf2030, perf3040 · Striate+, MODEL OCG-152, OCG-203, OCG-304, OCG-405 | — | — |
| Steritech, Inc. | United States | Contract sterilizer | D187800 | — | — |
| Dental Implant Technologies, Inc. | United States | Lister | Oradapt | — | — |
| LYNX Medical Pennsylvania | United States | Contract sterilizer | Optecure Dental | — | — |
| ZIMMER GmbH | Switzerland | Foreign exporter | ENDOBON XENOGRAFT GRANULES | — | — |
| Bausch Health US LLC | United States | Lister | — | — | — |
| Cook Inc. | United States | Contract sterilizer | — | — | — |
| GAMMATOM Srl | Italy | Contract sterilizer | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Parter Sterilization Services / Parter Medical Products | United States | Contract sterilizer | — | — | — |
| Systagenix Wound Management Manufacturing Limited | United Kingdom | Contract sterilizer | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental bone grafts are made
United States39South Korea13Germany10France6Switzerland5China5Finland4United Kingdom4Belgium3Brazil3
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC | 2 | 872.3930 | 44 | 231 |
| Intraoral Animal Source BarrierNPL | 2 | 872.3930 | 24 | 58 |
| Animal Source Bone Grafting MaterialNPM | 2 | 872.3930 | 21 | 42 |
| Intraoral Synthetic BarrierNPK | 2 | 872.3930 | 12 | 31 |
| Human Source Bone Grafting MaterialNUN | 2 | 872.3930 | 11 | 15 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Oct 2026 | K262415 | OSSIX Plus | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 9 Oct 2026 | K260096 | Wishbone HAE | Wishbone | NPM Animal Source Bone Grafting Material |
| 25 Sep 2026 | K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | HYUNDAI BIOLAND Co., Ltd. | NPM Animal Source Bone Grafting Material |
| 6 Jul 2026 | K253317 | Cytrans Elashield | GC America Inc. | LYC Synthetic Bone Grafting Material |
| 16 Jun 2026 | K253723 | BOSS | MEDPARK.Co., Ltd. | NPM Animal Source Bone Grafting Material |
| 14 May 2026 | K253883 | Bonalive Maxillofacial | Bonalive Ltd | LYC Synthetic Bone Grafting Material |
| 6 Mar 2026 | K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | LYC Synthetic Bone Grafting Material |
| 12 Dec 2025 | K242817 | Jason membrane | botiss biomaterials GmbH | NPL Intraoral Animal Source Barrier |
| 5 Dec 2025 | K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | NPL Intraoral Animal Source Barrier |
| 25 Nov 2025 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |
| 17 Sep 2025 | K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | LYC Synthetic Bone Grafting Material |
| 29 Aug 2025 | K243745 | FG Bone Graft B | Full Golden Biotech Co., Ltd. | LYC Synthetic Bone Grafting Material |
| 14 Aug 2025 | K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |
| 11 Jul 2025 | K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | NPM Animal Source Bone Grafting Material |
| 26 Jun 2025 | K251613 | SwissGraft X | Geistlich Pharma AG | NPM Animal Source Bone Grafting Material |
| 15 Apr 2025 | K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |
| 7 Mar 2025 | K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | NPM Animal Source Bone Grafting Material |
| 21 Feb 2025 | K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | LYC Synthetic Bone Grafting Material |
| 16 Aug 2024 | K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | NPM Animal Source Bone Grafting Material |
| 24 Jul 2024 | K230305 | THE Graft Collagen | PURGO BIOLOGICS Inc. | NPM Animal Source Bone Grafting Material |
| 12 Jul 2024 | K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | NPM Animal Source Bone Grafting Material |
| 1 May 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 16 Feb 2024 | K231513 | Oral Matrix | Beijing Biosis Healing Biological Technology Co., Ltd | NPL Intraoral Animal Source Barrier |
| 23 Jan 2024 | K231305 | Endoform Dental Membrane | Aroa Biosurgery Ltd | NPL Intraoral Animal Source Barrier |
| 8 Dec 2023 | K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | NPK Intraoral Synthetic Barrier |
| 13 Oct 2023 | K231672 | S1 | MEDPARK.Co., Ltd. | NPM Animal Source Bone Grafting Material |
| 6 Oct 2023 | K230091 | THE Cover | PURGO BIOLOGICS Inc. | NPL Intraoral Animal Source Barrier |
| 17 Aug 2023 | K223912 | InterCollagen® Guide | SigmaGraft, Inc. | NPL Intraoral Animal Source Barrier |
| 11 May 2023 | K222549 | OpenTex | PURGO BIOLOGICS Inc. | NPK Intraoral Synthetic Barrier |
| 18 Mar 2023 | K221808 | InterOss Collagen | SigmaGraft, Inc. | NPM Animal Source Bone Grafting Material |
| 24 Feb 2023 | K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | NPK Intraoral Synthetic Barrier |
| 30 Dec 2022 | K213260 | CMFlexTM | Dimension Inx Corp. | LYC Synthetic Bone Grafting Material |
| 30 Sep 2022 | K213904 | Kerecis Oral | Kerecis | NPL Intraoral Animal Source Barrier |
| 18 Aug 2022 | K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | NPK Intraoral Synthetic Barrier |
| 18 Jul 2022 | K212509 | OSSIX Breeze | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 5 Apr 2022 | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |
| 4 Mar 2022 | K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Inc. | LYC Synthetic Bone Grafting Material |
| 20 Aug 2021 | K211551 | Wishbone HA | Wishbone | NPM Animal Source Bone Grafting Material |
| 2 Apr 2021 | K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 3 Mar 2021 | K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |