Product Classification

• Device: adhesive, denture, carboxymethylcellulose sodium and cationic polyacrylamide polymer
• Regulation Description: Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: KOS
• Submission Type: PMA
• Regulation Number: 872.3420
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

Third Party Review

Not Third Party Eligible