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.
Recommended Actions
- Prepare detailed device description and comparison with predicate device
- Conduct performance testing according to relevant ISO standards
- Perform electrical safety and EMC testing
- Complete biocompatibility testing or reference predicate device
- Validate sterilization instructions and procedures
- Develop comprehensive labeling including all required safety information
- Document software validation if applicable
- Prepare risk analysis and mitigation measures
- Create detailed reprocessing instructions
- 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
- Device description including principles of operation and accessories
- Comparison table with predicate device
- Risk analysis and mitigation measures
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms
- 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
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