Device |
adhesive, denture, karaya with sodium borate |
Regulation Description |
Karaya and sodium borate with or without acacia denture adhesive. |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | KOR |
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 Standard
|
Third Party Review |
Not Third Party Eligible |
|
|