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 |