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U.S. Department of Health and Human Services

Product Classification

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Device restoration, resin
Definition Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
Review Panel Dental
Product CodeNSM
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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