Product Classification

• 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 Code: NXJ
• 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