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U.S. Department of Health and Human Services

Product Classification

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Device adhesive, denture, carboxymethylcellulose sodium and cationic polyacrylamide polymer
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKOS
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3420
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 Standards
Third Party Review Not Third Party Eligible
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