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U.S. Department of Health and Human Services

Product Classification

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Device resin, root canal filling containing chloroform
Regulation Description Root canal filling resin.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMMT
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 872.3820
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