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U.S. Department of Health and Human Services

Product Classification

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Device dentures, full
Definition Foreign dental lab manufactured full dentures are manufactured as finished products from denture resins.
Review Panel Dental
Product CodeNSL
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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