Prosthetic devices · 21 CFR 872 Subpart D
Karaya Denture Adhesive
FDA device type “Adhesive, Denture, Karaya”.
- Companies listing it
- 54 makers
- Brands and models
- 5
- 510(k) clearances
- 10 in five years
- FDA name
- Adhesive, Denture, Karaya
510(k) clearances per year, 1976–2026
Companies that list KOP
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Keystone Industries | United States | Maker | Cora-Caine | 2 | 2025 |
| one day dental partner | South Korea | Maker | kage ADHESIVE, DENTURE, KARAYA | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic Bonding | — | — |
| Modern Orthodontics | India | Maker | TruBond | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 3 Oct 1980 | K802285 | OHIO THORACIC SUCTION REGULATOR | Ohio Medical Products |
Official records: FDA product classification for KOP · 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