| Device |
bone grafting material, human source |
| Regulation Description |
Bone grafting material. |
| Definition |
Intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects.These defects may be surgically creatd osseous defects or osseous defects created from traumatic injry to the bone, inlcuding periodenta/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | NUN |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.3930
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
