Prosthetic devices · 21 CFR 872 Subpart D
Human Source Bone Grafting Material
INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.
- Companies listing it
- 1511 makers
- Brands and models
- 50
- 510(k) clearances
- 150 in five years
- FDA name
- Bone Grafting Material, Human Source
510(k) clearances per year, 1976–2026
Companies that list NUN
15 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Young Innovations Inc | United States | Maker | Allosculpt · AlloSculpt 3D Plus | 23 | 2025 |
| Keystone Dental Inc. | United States | Maker | Accell Connexus · DynaGraft · ORTHOBLAST II PASTE · PUTTY | 7 | 2024 |
| ZimVie US Corp LLC | United States | Maker | RegenerOss Allograft Putty · RegenerOss Allograft Putty Plus Mineralized | 1 | 2026 |
| Medtronic, Inc. | United States | Maker | Grafton DBM · Grafton DBM Paste · Grafton DBM Plus | 11 | 2014 |
| SeaSpine Orthopedics Corporation | United States | Maker | Accell Connexus Keystone Dental · DynaBlast Paste · DynaBlast Putty · DynaGraft D Gel · +3 | 2 | 2005 |
| Musculoskeletal Transplant Foundation | United States | Maker | DBX Dental | 2 | 2009 |
| 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 |
| Sotera Health LLC | United States | Maker | ACCELL CONNEXUS · ACCELL CONNEXUS KEYSTONE DENTAL · AlloSync CB Putty & Paste · bone grafting material, human source ACCELL CONNEXUS · +12 | — | — |
| Millstone Medical Outsourcing LLC | United States | Maker | RegenerOss | — | — |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | United States | Maker | AlloSculpt-3D Plus · Regenafil · Regenaform · Regenavate | — | — |
| Sweden & Martina INC | United States | Lister | BONE GRAFTING MATERIAL, HUMAN | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | C-Blast Putty · C-Graft Putty · DynaBlast · DynaGraft-D | — | — |
| LYNX Medical Pennsylvania | United States | Contract sterilizer | Optecure Dental | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Jan 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. |
| 20 Jan 2012 | K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | Biomet Interpore Cross |
| 12 Aug 2011 | K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | Exactech, Inc. |
| 2 Oct 2009 | K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | Musculoskeletal Transplant Foundation |
| 10 Nov 2008 | K082463 | PROGENIX | Medtronic Sofamor Danek |
| 18 Jul 2008 | K081950 | PROGENIX PLUS | Medtronic Sofamor Danek |
| 13 May 2008 | K080462 | PROGENIX DBM PUTTY | Medtronic Sofamor Danek |
| 30 Apr 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST | Regeneration Technologies, Inc. |
| 14 May 2007 | K070147 | INTERGRO ORAL | Biomet 3i, LLC |
| 29 Mar 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Isotis NV |
| 27 Mar 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | Isotis NV |
| 3 Jan 2006 | K051188 | GRAFTON DBM | Medtronic, Inc. |
| 30 Nov 2005 | K042707 | GRAFTON PLUS DBM PASTE | Medtronic, Inc. |
| 29 Jul 2005 | K043573 | DYNAGRAFT II DENTAL | SeaSpine Orthopedics Corporation |
| 29 Apr 2005 | K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | Musculoskeletal Transplant Foundation |
Official records: FDA product classification for NUN · 21 CFR 872.3930.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026