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U.S. Department of Health and Human Services

Product Classification

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Device denture, cosmetic only
Definition Intended to improve an individual's appearance only.Not intended to assist in chewing food.
Physical State denture rebasing resin, methylmethacrylate
Technical Method Functions independently
Target Area oral cavity
Review Panel Dental
Product CodeNXJ
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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