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U.S. Department of Health and Human Services

Product Classification
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Device restoration, porcelain
Definition Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
Review Panel Dental
Product CodeNSP
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT 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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