| Device Type ID | 1156 |
| Device Name | Cleanser, Denture, Over The Counter |
| Regulation Description | OTC Denture Cleanser. |
| 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 | 872.3520 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EFT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1156 |
| Device | Cleanser, Denture, Over The Counter |
| Product Code | EFT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | OTC Denture Cleanser. |
| CFR Regulation Number | 872.3520 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Patient-Device Incompatibility | 2 |
Material Discolored | 1 |
Product Quality Problem | 1 |
Use Of Device Problem | 1 |
Reaction | 1 |
Break | 1 |
Nonstandard Device | 1 |
| Total Device Problems | 12 |