Prosthetic devices · 21 CFR 872 Subpart D
Over the Counter Wax Impregnated Cotton Denture Pad Cushion
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
- Companies listing it
- 139 makers
- Brands and models
- 16
- 510(k) clearances
- 00 in five years
- FDA name
- Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
Companies that list NKJ
13 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Spanch | 5 | 2022 |
| Prestige Brands Holdings, Inc. | United States | Maker | EZO Denture Cushions (Upper and Lower) | 1 | 2013 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | cushion / liner · denture · over-the-counter product · pad · +1 | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | CUSHION, PAD, DENTURE, WAX IMPREGNATED COTTON, OVER THE COUNTER | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | Cotton Pad | — | — |
| Danameco Medical Joint Stock Corporation | Vietnam | Maker | D-Care · WAX IMPREGNATED COTTON | — | — |
| GuangZhou Nuoning Medical Supplies Co.,Ltd | China | Maker | Cushion, Pad, Denture, Wax Impregnated Cotton, Over the Counter-Flaux Skin Pad, Injection Pratice pad · Injection Pratice pad, Injection Training Pad | — | — |
| ADDEV Materials Healthcare (Mazzola) | United States | Maker | — | — | — |
| Innovize | United States | Maker | — | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental wax | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Cotton Pad | — | — |
Official records: FDA product classification for NKJ · 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