# Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
> **Product code: NKJ** · Class I — Low Risk (general controls) · Dental · 21 CFR 872.3540
## Classification
- **FDA Product Code:** NKJ
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 872.3540
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NKJ)
---
*AI Analytics · CC0 1.0*