Prosthetic devices · 21 CFR 872 Subpart D
Over the Counter Denture Cushion
FDA device type “Cushion, Denture, Over The Counter”.
- Companies listing it
- 54 makers
- Brands and models
- 4
- 510(k) clearances
- 30 in five years
- FDA name
- Cushion, Denture, Over The Counter
510(k) clearances per year, 1976–2026
Companies that list EHS
5 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Bonyf AG | Liechtenstein | Maker | cushion, denture, over the counter · DENTTACH COMFORT Denture Relining Cushion | 1 | 2006 |
| one day dental partner | South Korea | Maker | kage Cushion, denture, over the counter | — | — |
| Anhui Greenland Biotech Co.,Ltd | China | Maker | — | — | — |
| Think Big Industrial Company Limited | China | Maker | Adhesive Denture Cushions | — | — |
| DSI Dental Solutions Ltd | Israel | Manufacturer | — | 2 | 2025 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Jul 1997 | K971002 | SMILE WITH CONFIDENCE | Lloyd V. Ziemendorf |
| 5 Feb 1982 | K813190 | SOFT PLATE CUSHION | Leonard Russo Co. |
| 24 Jun 1977 | K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | Combe, Inc. |
Official records: FDA product classification for EHS · 21 CFR 872.3540.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026