Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

Device Code: 1322

Product Code(s): MMU

Device Classification Information

• Device Type ID: 1322
• Device Name: 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
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: PMA
• CFR Regulation Number: 872.3400 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: MMU
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 1322
• Device: Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
• Product Code: MMU
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Karaya And Sodium Borate With Or Without Acacia Denture Adhesive.
• CFR Regulation Number: 872.3400 [🔎]

TPLC Last Update: 2019-04-02 19:52:00