FDA product code NKJ

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

Dental·Class 1·21 CFR 872.3540
US regulatory classifications
US Product Code (FDA)
NKJ
View Product Code Classification →
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 872.3540
View CFR Regulation →
Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.