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, INLC
| Device Type ID | 1358 |
| Device Name | Bone Grafting Material, Human Source |
| 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 | 510(k) |
| CFR Regulation Number | 872.3930 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1358 |
| Device | Bone Grafting Material, Human Source |
| Product Code | NUN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HANS BIOMED CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6 |
Appropriate Term/Code Not Available | 5 |
Insufficient Information | 4 |
Break | 1 |
Seal | 1 |
Failure To Adhere Or Bond | 1 |
| Total Device Problems | 18 |