Premarket Notification Requirements for Dental Curing Light Devices (DRAFT)
This guidance applies to dental curing lights regulated under 21 CFR 872.6070 with product code EBZ (Activator, Ultraviolet, for Polymerization). It excludes laser devices for polymerization and devices exclusively for tooth whitening procedures.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are the key performance testing requirements for dental curing lights in 510(k) submissions?
FDA recommends testing for radiant power output, heat generation, and depth of cure. Testing should follow ISO 10650 standards and demonstrate the device provides appropriate energy for photopolymerization while maintaining safe temperature levels for patients and practitioners.
How do I determine the appropriate biocompatibility testing for dental curing light patient-contacting materials?
For surface devices with limited contact duration, you must address cytotoxicity, sensitization, and irritation endpoints per ISO 7405. If materials match legally marketed predicates with identical composition and manufacturing, you may reference previous testing or literature.
What cybersecurity documentation is required for networked dental curing lights?
If your device meets the cyber device definition under section 524B(c) of the FD&C Act, cybersecurity documentation is required. Follow FDA’s guidance “Cybersecurity in Medical Devices” for quality system considerations and premarket submission content requirements.
What software documentation level applies to dental curing lights with device software functions?
FDA generally considers dental curing light software functions to need “Basic” Documentation Level per the premarket device software guidance. However, new indications, applications, or unusual technological characteristics may require Enhanced Documentation Level.
Which electrical safety standards must dental curing lights comply with for FDA submission?
Dental curing lights should be tested per IEC 60601-1 (general medical electrical equipment), IEC 80601-2-60 (dental equipment specific requirements), and IEC 60601-1-2 (electromagnetic compatibility) with relevant U.S. national differences applied.
What labeling information must be included for dental curing light reprocessing instructions?
Instructions must address disassembly, cleaning, disinfection/sterilization, and reassembly procedures. Include guidance on disposable sleeves, protective equipment use, irradiance checking, thermal hazard warnings, and validation methods per FDA’s reprocessing guidance.
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive device characterization including radiant power output, heat generation, and depth of cure testing
- Perform electrical safety and EMC testing according to relevant standards
- Complete biocompatibility evaluation for patient-contacting materials
- Develop detailed labeling including all required specifications and safety information
- Prepare software documentation appropriate to device complexity
- Validate reprocessing procedures and instructions
- Assess cybersecurity requirements and implement necessary controls
- If wireless technology is used, conduct additional RF testing
- Document all testing results in appropriate format for 510(k) submission
- Ensure all modifications are properly evaluated for need of new 510(k)
Key Considerations
Non-clinical testing
- Radiant power output testing according to ISO 10650
- Heat generation testing under normal and fault conditions
- Depth of cure testing on representative dental restorative resin
- Electrical safety testing according to IEC 60601-1 and IEC 80601-2-60
- EMC testing according to IEC 60601-1-2
Software
- Basic documentation level typically required
- Full description of software functions
- Validation and verification documentation
- Additional requirements for OTS software if applicable
Cybersecurity
- Required documentation if device meets cyber device definition
- Assessment of cybersecurity risks and mitigations
Labelling
- Total radiant power output specifications
- Maximum light intensity specifications
- Peak wavelength information
- Recommended distance and angle of use
- Recommended curing times
- Instructions for protective equipment use
- Reprocessing instructions
- Warnings about thermal hazards
Biocompatibility
- Testing required for patient-contacting materials:
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
Safety
- Electrical safety testing
- EMC testing
- Heat generation safety limits
- Protection against excessive radiation
Other considerations
- Wireless technology testing if applicable
- Reprocessing validation
- Performance testing for modifications
Relevant Guidances đź”—
- Dental Curing Lights - Performance Testing and Safety Requirements
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms đź“‚
- ISO 10650: Dentistry – Powered Polymerization Activators
- IEC 60601-1: Medical electrical equipment – General requirements for basic safety
- IEC 80601-2-60: Medical electrical equipment - Particular requirements for dental equipment
- IEC 60601-1-2: EMC requirements for medical electrical equipment
- ISO 7405: Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- ISO 12609-1: Eyewear for protection against intense light sources
- ISO 12609-2: Eyewear for protection - Guidance for use