NPM — Bone Grafting Material, Animal Source Class II
FDA product code NPM covers "Bone Grafting Material, Animal Source", a Class II medical device regulated under 21 CFR 872.3930. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253723 | medpark co | BOSS | June 16, 2026 |
| 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 |