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U.S. Department of Health and Human Services

Product Classification

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Device adhesive, denture, polyacrylamide polymer (modified cationic)
Regulation Description Polyacrylamide polymer (modified cationic) denture adhesive.
Definition Call for PMAs 12/26/96 per 61 FR 50707 on 9/26/96
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKON
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3480
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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