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U.S. Department of Health and Human Services

Product Classification

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Device adhesive, denture, karaya with sodium borate
Regulation Description Karaya and sodium borate with or without acacia denture adhesive.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKOR
Premarket Review Dental Devices (DHT1B)
Dental Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3400
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
Third Party Review Not Third Party Eligible
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