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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
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3500
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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