Dental Curing Lights - Performance Testing and Safety Requirements
This guidance applies to dental curing lights used for photoactivation of resins and dental bleaching agents (class II devices) that use light sources such as quartz-tungsten-halogen lamps, LEDs, xenon-plasma arcs, and lasers. It excludes heat or light sources intended exclusively for tooth bleaching procedures.
Recommended Actions
- Conduct performance testing according to ANSI/ADA Specification No. 48
- Perform electrical safety and EMC testing
- Develop and validate infection control procedures
- Create comprehensive device labeling including all required elements
- Prepare detailed comparison to predicate devices
- Validate thermal and optical radiation safety
- If software-controlled, ensure software documentation meets requirements
- Document all testing results and validation data for 510(k) submission
- Develop clear reprocessing instructions for end users
- Ensure compliance with laser requirements if applicable
Key Considerations
Non-clinical testing
- Evaluate irradiance at 2mm from light guide showing maximum light intensity (mW/cm2)
- Provide spectral irradiance plot showing peak wavelength (nm)
- Demonstrate depth of cure on representative resin sample
- Validate that device does not present thermal hazard during longest prescribed curing times
- Validate that optical radiation emissions do not present hazards during maximum exposure times
Software
- Follow FDA guidance for software contained in medical devices if device is software-controlled
- Follow general principles of software validation
Labelling
- Include maximum light intensity
- Include peak wavelength
- List compatible curing systems
- Include warnings about optical radiation and thermal hazards
- Provide detailed reprocessing instructions (disassembly, cleaning, disinfection/sterilization, etc.)
- Comply with laser labeling requirements if applicable (21 CFR 1040.10(g))
Safety
- Demonstrate electrical safety compliance
- Demonstrate electromagnetic compatibility (EMC)
- Validate infection control procedures including disinfection/sterilization parameters
- Validate that patient-contacting portions do not present thermal hazards
Other considerations
- Describe principles of operation
- Provide comparison to predicate devices
- Include device design details (operational modes, light source, power source)
- Specify material composition of patient-contacting portions
Relevant Guidances
- Premarket Notification Requirements for Dental Curing Light Devices (Draft)
- Content of Premarket Submissions for Device Software Functions
- 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
- ANSI/ADA Specification No. 48: Visible Light Curing Units, 2004
- IEC 60601-1:1988: Medical Electrical Equipment – Part 1: General requirements for safety
- IEC 60601-1-2:1993: Medical Electrical Equipment – Part 1: General requirements for safety – 2. Collateral Standard: Electromagnetic compatibility
Original guidance
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