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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cushion, pad, denture, wax impregnated cotton, over the counter
Regulation Description OTC denture cushion or pad.
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.
Product CodeNKJ
Regulation Number 872.3540
Device Class 1