Definition: An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implan
| Device Type ID | 1348 |
| Device Name | Barrier, Animal Source, 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 | NPL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1348 |
| Device | Barrier, Animal Source, Intraoral |
| Product Code | NPL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Grafting Material. |
| CFR Regulation Number | 872.3930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COLLAGEN MATRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DATUM DENTAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GEISTLICH PHARMA AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INSTITUT STRAUMANN AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MATRICEL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NIBEC CO LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRAUMANN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 26 |
Appropriate Term/Code Not Available | 4 |
Loss Of Or Failure To Bond | 1 |
Material Disintegration | 1 |
Device Operates Differently Than Expected | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 34 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biom'up | II | Jan-27-2017 |