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U.S. Department of Health and Human Services

Product Classification

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Device restoration, base metal
Definition Foreign dental lab manufactured base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.
Review Panel Dental
Product CodeNSQ
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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