| Device Type ID | 1184 |
| Device Name | Dam, Rubber |
| 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 | EIE |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1184 |
| Device | Dam, Rubber |
| Product Code | EIE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rubber Dam And Accessories. |
| CFR Regulation Number | 872.6300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENALI CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Integrity Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Patient-Device Incompatibility | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Coltene Whaledent Inc | II | Aug-06-2014 |