Gel, Electrode, For Pulp Tester

Device Code: 1112

Product Code(s): EAS

Device Classification Information

• Device Type ID: 1112
• Device Name: Gel, Electrode, For Pulp Tester
• Regulation Description: Electrode Gel For Pulp Testers.
• 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: 510(K) Exempt
• CFR Regulation Number: 872.1730 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EAS
• 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: 1112
• Device: Gel, Electrode, For Pulp Tester
• Product Code: EAS
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Electrode Gel For Pulp Testers.
• CFR Regulation Number: 872.1730 [🔎]

TPLC Last Update: 2019-04-02 19:48:33