Prosthetic devices · 21 CFR 872 Subpart D
Acacia and Karaya with Sodium Borate Denture Adhesive
FDA device type “Adhesive, Denture, Acacia And Karaya With Sodium Borate”.
- Companies listing it
- 32 makers
- Brands and models
- 3
- 510(k) clearances
- 10 in five years
- FDA name
- Adhesive, Denture, Acacia And Karaya With Sodium Borate
510(k) clearances per year, 1976–2026
Companies that list KOM
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Adhesive, Denture (All types) | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Adhesive, Denture, Acacia And Karaya With Sodium Borate models X-SMALL,X-LARGE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Mar 1991 | K910216 | STEADFAST DENTURE ADHESIVE POWDER | Stiefel Research Institute, Inc. |
Official records: FDA product classification for KOM · 21 CFR 872.3400.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026