| Device |
bone grafting material, animal source |
| Regulation Description |
Bone grafting material. |
| 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. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | NPM |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.3930
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
