Prosthetic devices · 21 CFR 872 Subpart D
Karaya and Ethylene-Oxide Homopolymer Denture Adhesive
FDA device type “Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer”.
- Companies listing it
- 32 makers
- Brands and models
- 3
- 510(k) clearances
- 10 in five years
- FDA name
- Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
510(k) clearances per year, 1976–2026
Companies that list KXX
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Combe, Inc. | United States | Maker | SEA BOND DENTURE ADHESIVE | 4 | 1994 |
| one day dental partner | South Korea | Maker | kage ADHESIVE, DENTURE, KARAYA AND ETHYLENE-OXIDE HOMOPOLYMER | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Sep 1986 | K863375 | SEA-BOND | Combe, Inc. |
Official records: FDA product classification for KXX · 21 CFR 872.3450.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026