Definition: OTC Denture Cushion Or Pad Made Of Wax Impregnated Cotton Cloth That The Patient Applies To The Base Or Inner Surface Of A Denture Before Inserting The Denture Into The Mouth. The Device Is Intended To Be Discarded Following 1 Day's Use.
| Device Type ID | 1340 |
| Device Name | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter |
| Regulation Description | OTC Denture Cushion Or Pad. |
| 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 | 872.3540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NKJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1340 |
| Device | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter |
| Product Code | NKJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | OTC Denture Cushion Or Pad. |
| CFR Regulation Number | 872.3540 [🔎] |