An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis…
An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.
Who Else Makes It
Concentrated in Hebei (1), Shanghai (1), Jiangsu (1).
Record
Regulatory record for Secure Denture Cushion Strips | Listed by | Fittydent Intl. Gmbh, Austria |
| FDA product code | KOQ |
| Device type | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-02 |
| Record revised | 2023-12-04 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-12-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.