Data / Medical devices / Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter (NKJ): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter (product code NKJ, Class 1, 21 CFR 872.3540). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- NKJ
- Device class
- 1
- Regulation
- 872.3540
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Turkey | 1 |
| Vietnam | 1 |
Makers of Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ADDEV Materials Healthcare | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Konya, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovize | North Oaks, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.