Product Classification

• Device: restoration, noble metal
• Definition: Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.
• Review Panel: Dental
• Product Code: NSJ
• Premarket Review: Division of Dental and ENT Devices (DHT1B); 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