NPM — Bone Grafting Material, Animal Source Class II
Classification Details
- Product Code
- NPM
- Device Class
- Class II
- Regulation Number
- 872.3930
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251786 | geistlich pharma | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | July 11, 2025 |
| K251613 | geistlich pharma | SwissGraft X | June 26, 2025 |
| K242510 | geistlich pharma | Geistlich Bio-Flow® | March 7, 2025 |
| K240133 | collagen solutions | Xenograft Bovine Bone Particulate | August 16, 2024 |
| K230305 | purgo biologics | THE Graft Collagen | July 24, 2024 |
| K240661 | geistlich pharma | Geistlich Bio-Oss® | July 12, 2024 |
| K231672 | medpark co | S1 | October 13, 2023 |
| K221808 | sigmagraft | InterOss Collagen | March 18, 2023 |
| K211551 | wishbone | Wishbone HA | August 20, 2021 |
| K202183 | collagen matrix | Porcine Mineral Collagen Composite | April 2, 2021 |
| K201859 | collagen matrix | Porcine Mineral Collagen Composite Moldable | September 11, 2020 |
| K193212 | dsm biomedical | DSM Biomedical Dental Bone Graft Plus | September 10, 2020 |
| K191737 | purgo biologics | The Graft Bone Substitute | February 14, 2020 |
| K173594 | institut straumann | Straumann cerabone | October 19, 2018 |
| K173188 | purgo biologics | The Graft Natural Bone Substitute | July 20, 2018 |
| K171008 | collagen matrix | Anorganic Bone Mineral with Collagen in Delivery Applicator | October 30, 2017 |
| K163714 | datum dental | OSSIX BONE | July 18, 2017 |
| K170541 | collagen matrix | Anorganic Bone Mineral in Delivery Applicator | July 7, 2017 |
| K170245 | kensey nash corporation dba dsm biomedical | DSM Biomedical Dental Bone Graft | May 16, 2017 |
| K162158 | collagen matrix | Porcine Anorganic Bone Mineral in Delivery Applicator | February 9, 2017 |