| Device Type ID | 1294 |
| Device Name | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| Regulation Description | Carboxymethylcellulose Sodium And/or Polyvinylmethylether Maleic Acid Calcium-sodium Double Salt Denture Adhesive. |
| 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 | 872.3490 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KOO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1294 |
| Device | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| Product Code | KOO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Carboxymethylcellulose Sodium And/or Polyvinylmethylether Maleic Acid Calcium-sodium Double Salt Denture Adhesive. |
| CFR Regulation Number | 872.3490 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 59 |
Appropriate Term/Code Not Available | 8 |
Loss Of Or Failure To Bond | 1 |
Insufficient Information | 1 |
| Total Device Problems | 69 |