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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 Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type PMA
Regulation Number 872.3480
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible