Product Classification

• Device: adhesive, denture, acacia and karaya with sodium borate > 12% by weight
• Regulation Description: Karaya and sodium borate with or without acacia denture adhesive.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: MMU
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: PMA
• Regulation Number: 872.3400
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 4-284 ISO 10873 Second edition 2021-07
  Dentistry - Denture adhesives

Third Party Review

Not Third Party Eligible