Kit, Test, In Vitro Periodontal

Device Code: 1407

Product Code(s): MCL

Device Classification Information

• Device Type ID: 1407
• Device Name: Kit, Test, In Vitro Periodontal
• 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
• FDA Device Classification: Class 3 Medical Device
• Product Code: MCL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1407
• Device: Kit, Test, In Vitro Periodontal
• Product Code: MCL
• FDA Device Classification: Class 3 Medical Device

TPLC Last Update: 2019-04-02 19:53:37