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Dental Handpieces - Performance Testing, Safety Requirements and Labeling

This guidance covers Class I dental handpieces including air-powered high speed handpieces, air-powered micromotors, contra-angle attachments, straight attachments, oscillating endodontic contra-angles, and AC-powered handpiece systems with controller console, foot control, DC-powered micromotor, and lubricants. These devices are intended to prepare dental cavities for restorations and clean teeth.

  1. Prepare detailed device description and comparison with predicate device
  2. Conduct performance testing according to relevant ISO standards
  3. Perform electrical safety and EMC testing
  4. Complete biocompatibility testing or reference predicate device
  5. Validate sterilization instructions and procedures
  6. Develop comprehensive labeling including all required safety information
  7. Document software validation if applicable
  8. Prepare risk analysis and mitigation measures
  9. Create detailed reprocessing instructions
  10. Compile all test results and documentation for 510(k) submission

Key Considerations

Non-clinical testing

  • Performance testing according to ISO standards for:
    • Speed ranges (rpm)
    • Air pressure limits
    • Bur release force
    • Chuck design
    • Coupling dimensions
    • Hose connections
  • Validation of sterilization cycles impact on performance
  • Thermal safety testing

Software

  • Software documentation based on level of concern (minor, moderate, or major)
  • Follow FDA guidance for software-controlled medical devices

Labelling

  • Maximum speed in rpm
  • Connector types
  • Chuck type specifications
  • Thermal hazard warnings
  • Maintenance requirements
  • Lubricant hazard warnings
  • Operating speeds with gear ratios
  • Detailed reprocessing instructions (disassembly, cleaning, lubrication, sterilization, etc.)

Biocompatibility

  • Testing for limited contact with mucosal tissue
  • Selection of tests based on duration and level of patient contact
  • Can reference predicate device if identical materials and processing

Safety

  • Electrical safety testing per IEC 60601-1
  • EMC testing per IEC 60601-1-2
  • Thermal safety demonstration
  • Prevention of cross-contamination

Other considerations

  • ISO 7785-1: High-speed Air Turbine Handpieces
  • ISO 7785-2: Straight and Geared Angle Handpieces
  • ISO 1797: Dental Rotary Instruments – Shanks
  • ISO 3964: Dental Handpieces – Coupling Dimensions
  • ISO 9168: Dental Handpieces – Hose Connections
  • ISO 9687: Dental Equipment – Graphical Symbols
  • ISO 11498: Dental Handpieces: Dental Low Voltage Electrical Motors
  • ISO 13294: Dental Handpieces – Dental Air-Motors
  • IEC 60601-1: Medical Electrical Equipment – General requirements for safety
  • IEC 60601-1-2: Medical Electrical Equipment – EMC requirements

Original guidance

  • Dental Handpieces - Performance Testing, Safety Requirements and Labeling
  • HTML / PDF
  • Issue date: 2007-05-02
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: da3e33ed3587e2325ba371439aafa38a
This post is licensed under CC BY 4.0 by the author.