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U.S. Department of Health and Human Services

Product Classification
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Device polyvinyl methylether maleic anhydride &/or acid copolymer & carboxymethylce
Regulation Description Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
Definition Call for pmas 12/26/96 per 61 fr 50707 on 9/27/96.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKXY
Submission Type PMA
Regulation Number 872.3500
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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