Product code
NKJ: Cushion, pad, denture, wax impregnated cotton, over the counter
FDA product code · Class I · Dental
Key facts
| Product code | NKJ |
|---|---|
| Device | Cushion, pad, denture, wax impregnated cotton, over the counter |
| Device class | Class I |
| Regulation number | 872.3540 |
| Review panel | Dental |
| Medical specialty | Dental |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database