Product code NPM
- Device name
- Bone Grafting Material, Animal Source
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3930
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P860012S005 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1995-03-21 |
| P860012S004 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1990-09-12 |
| P860012S002 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1990-07-17 |
| P860012S003 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1990-07-06 |
| P860012S001 | ALVEOFORM TM BIOGRAFT | Collagen Corp. | 1988-12-13 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | 2025-07-11 |
| K251613 | SwissGraft X | Geistlich Pharma AG | 2025-06-26 |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025-03-07 |
| K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | 2024-08-16 |
| K230305 | THE Graft Collagen | Purgo Biologics, Inc. | 2024-07-24 |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024-07-12 |
| K231672 | S1 | Medpark Co., Ltd. | 2023-10-13 |
| K221808 | InterOss Collagen | Sigmagraft, Inc. | 2023-03-18 |
| K211551 | Wishbone HA | Wishbone SA | 2021-08-20 |
| K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | 2021-04-02 |
| K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | 2020-09-11 |
| K193212 | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | 2020-09-10 |
| K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | 2020-02-14 |
| K173594 | Straumann cerabone | Institut Straumann AG | 2018-10-19 |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | 2018-07-20 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | 2017-10-30 |
| K163714 | OSSIX BONE | Datum Dental, Ltd. | 2017-07-18 |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-07-07 |
| K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | 2017-05-16 |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-02-09 |
| K151542 | A-Oss | Hiossen, Inc. | 2016-08-03 |
| K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | Nibec Co., Ltd. | 2015-12-10 |
| K151209 | InterOss | Sigmagraft, Inc. | 2015-11-06 |
| K142040 | OCS-B COLLAGEN | Nibec Co., Ltd. | 2015-07-31 |
| K140021 | TI-OSS | Chiyewon | 2015-06-05 |
| K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | 2014-07-16 |
| K123876 | SYNERGY | Odontit S.A. | 2014-05-22 |
| K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC | Geistlich Pharma AG | 2013-02-15 |
| K113246 | OCS-B | Nibec Company, Limited | 2013-01-16 |
| K120152 | CERASORB PLUS | Riemser Arzneimittel AG | 2012-08-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800039000154 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000291 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000284 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000277 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000260 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000253 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000246 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000239 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000222 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000215 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000208 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000192 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000185 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000178 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000161 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000000 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000147 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000130 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000123 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000116 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000109 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000093 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000086 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000079 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000062 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000055 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000048 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000031 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000024 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |
| 08800039000017 | THE Graft | PURGO BIOLOGICS Inc. | 2018-10-15 |