| Device Type ID | 1144 |
| Device Name | Clamp, Rubber Dam |
| Regulation Description | Rubber Dam And Accessories. |
| 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) Exempt |
| CFR Regulation Number | 872.6300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EEF |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1144 |
| Device | Clamp, Rubber Dam |
| Product Code | EEF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rubber Dam And Accessories. |
| CFR Regulation Number | 872.6300 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 11 |
Use Of Device Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Shelf Life Exceeded | 2 |
Loss Of Or Failure To Bond | 1 |
Pitted | 1 |
| Total Device Problems | 20 |