Definition: A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
| Device Type ID | 1314 |
| Device Name | Bone Grafting Material, Synthetic |
| 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 | LYC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1314 |
| Device | Bone Grafting Material, Synthetic |
| Product Code | LYC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GENOSS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNICARE BIOMEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 112 |
Failure To Osseointegrate | 28 |
Osseointegration Problem | 20 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Device Operates Differently Than Expected | 4 |
Patient-Device Incompatibility | 3 |
Migration Or Expulsion Of Device | 2 |
Shelf Life Exceeded | 2 |
Device Expiration Issue | 1 |
Material Separation | 1 |
Device Appears To Trigger Rejection | 1 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
Delamination | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 189 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet 3i, LLC | III | Mar-19-2014 |
| 2 | Biomet France SARL | II | Feb-09-2016 |
| 3 | Collagen Matrix, Inc. | III | Nov-09-2018 |
| 4 | Osteogenics Biomedical, Inc. | II | Oct-18-2016 |