NKJ — Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter Class I
FDA product code NKJ covers "Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter", a Class I medical device regulated under 21 CFR 872.3540. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- NKJ
- Device Class
- Class I
- Regulation Number
- 872.3540
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- 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.