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