Product Classification

• Device: unit, x-ray, intraoral
• Regulation Description: Intraoral source x-ray system.
• Regulation Medical Specialty: Dental
• Review Panel: Radiology
• Product Code: EAP
• Premarket Review: Office of In Vitro Diagnostics and Radiological Health (OIR)
• Submission Type: 510(k)
• Regulation Number: 872.1810
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Recognized Consensus Standards

• 12-221 IEC 61223-3-4 First edition 2000-03
  Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
• 12-310 IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• accelerated device approval services
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc