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U.S. Department of Health and Human Services

Product Classification

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Device dentures, partial
Definition Foreign dental lab manufactured partial dentures are manufactured as finished products from denture resins and other supporting materials.
Review Panel Dental
Product CodeNSK
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
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
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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