Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
Medical specialty
Dental
Device class
1
Regulation number
872.3540
Review panel
DE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
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.