NKJ
- Product code
- NKJ
- Device name
- Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
- Device class
- Class 1
- 21 CFR
- 21 CFR 872.3540
- Medical specialty
- Dental
- Marketing pathway
- 510(K) Exempt
FDA classification 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.
Official FDA classification page: NKJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).