Definition: A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.
| Device Type ID | 1349 |
| Device Name | Bone Grafting Material, Animal 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 | NPM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1349 |
| Device | Bone Grafting Material, Animal Source |
| Product Code | NPM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHIYEWON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLLAGEN MATRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HIOSSEN INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTITUT STRAUMANN AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIBEC CO LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ODONTIT SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRAUMANN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Osseointegrate | 8 |
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Collagen Matrix Inc | III | Jan-17-2019 |
| 2 | Collagen Matrix Inc | III | Mar-15-2016 |
| 3 | Collagen Matrix Inc | II | Mar-11-2016 |
| 4 | Collagen Matrix Inc | II | Mar-11-2016 |