| Device Type ID | 1092 |
| Device Name | Mouthpiece, Saliva Ejector |
| Regulation Description | Dental Operative Unit 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 | 872.6640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DYN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1092 |
| Device | Mouthpiece, Saliva Ejector |
| Product Code | DYN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Operative Unit And Accessories. |
| CFR Regulation Number | 872.6640 [🔎] |
| Device Problems | |
|---|---|
Tip | 4 |
Detachment Of Device Component | 3 |
Component Falling | 1 |
Detachment Of Device Or Device Component | 1 |
Appropriate Term/Code Not Available | 1 |
Device Dislodged Or Dislocated | 1 |
Material Integrity Problem | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 13 |