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 Ti
| Device Type ID | 1350 |
| Device Name | Bone Grafting Material, Dental, With Biologic Component |
| Regulation Description | Bone Grafting Material. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | PMA |
| CFR Regulation Number | 872.3930 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NPZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1350 |
| Device | Bone Grafting Material, Dental, With Biologic Component |
| Product Code | NPZ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Migration Or Expulsion Of Device | 2 |
| Total Device Problems | 6 |