Definition: A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.
| Device Type ID | 1347 |
| Device Name | Barrier, Synthetic, Intraoral |
| 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 | NPK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1347 |
| Device | Barrier, Synthetic, Intraoral |
| Product Code | NPK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NEOSS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOGENICS BIOMEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Barrier | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Inion Ltd. | II | Mar-16-2017 |