Unit, Electrosurgical, And Accessories, Dental

Device Code: 1236

Product Code(s): EKZ

Device Classification Information

• Device Type ID: 1236
• Device Name: Unit, Electrosurgical, And Accessories, Dental
• Regulation Description: Dental Electrosurgical Unit And Accessories.
• 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)
• CFR Regulation Number: 872.4920 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EKZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

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: 1236
• Device: Unit, Electrosurgical, And Accessories, Dental
• Product Code: EKZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Dental Electrosurgical Unit And Accessories.
• CFR Regulation Number: 872.4920 [🔎]

Device Problems
Application Program Problem: Dose Calculation Error	4
Programming Issue	1
Patient Device Interaction Problem	1
Total Device Problems	6

TPLC Last Update: 2019-04-02 19:50:26