| Device |
bone grafting material, dental, with biologic component |
| Regulation Description |
Bone grafting material. |
| Definition |
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | NPZ |
|---|
| Submission Type |
PMA
|
|---|
| Regulation Number |
872.3930
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
