NPM
- Product code
- NPM
- Device name
- Bone Grafting Material, Animal Source
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3930
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 40 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253723 | 2026-06-16 | Medpark Co., Ltd. | BOSS | |
| K251786 | 2025-07-11 | Geistlich Pharma AG | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | FDA |
| K251613 | 2025-06-26 | Geistlich Pharma AG | SwissGraft X | |
| K242510 | 2025-03-07 | Geistlich Pharma AG | Geistlich Bio-Flow® | FDA |
| K240133 | 2024-08-16 | Collagen Solutions, LLC | Xenograft Bovine Bone Particulate | |
| K230305 | 2024-07-24 | Purgo Biologics, Inc. | THE Graft Collagen | |
| K240661 | 2024-07-12 | Geistlich Pharma AG | Geistlich Bio-Oss® | |
| K231672 | 2023-10-13 | Medpark Co., Ltd. | S1 |
Official FDA classification page: NPM
Classification and pathway per current FDA publications. Data from openFDA (CC0).