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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 Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT 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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible