Definition: Other Dental Material With Growth Factors Is A Material, Used With Or Without Other Devices, 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 Max
| Device Type ID | 1351 |
| Device Name | Biologic Material, Dental |
| 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 | NQA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1351 |
| Device | Biologic Material, Dental |
| Product Code | NQA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Straumann Manufacturing, Inc. | II | May-04-2018 |