inforMED
NKJClass I

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

Dental · 21 CFR 872.3540

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.

MDR events1All time
Recalls0All time
Registered firms15Currently listed
510(k) clearances0All time

Event type breakdown

Other1

Most-reported manufacturers

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Recalls

0 recall events for this product code

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No recalls on file for this product code.

510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.