Technical Performance Testing for Dental Cements and Resin-Modified Materials
This guidance covers dental cements classified as Class II devices under specific product codes (EMA, KLE, DYH), including: - Water-based cements (powder/liquid acid-base cements) - Resin-modified cements - Dental composite resins that are combination products The devices are intended for temporary tooth filling, base cement for temporary filling, affixing dental devices (crowns, bridges, orthodontic brackets), or tooth protection and restoration retention.
Recommended Actions
- Determine if your device falls within the scope of this guidance
- Conduct all required non-clinical testing according to specified methodologies
- Perform complete biocompatibility evaluation as per FDA guidance
- Prepare test reports and Declarations of Conformity (DoC) for all applicable tests
- Consider submitting a Pre-Submission if additional testing beyond guidance requirements is needed
- Compile all test results summaries and supporting documentation for 510(k) submission
- Ensure all performance criteria are met before submission
- Document any deviations with proper justification
- If using identical materials as predicate device, prepare documentation for biocompatibility rationale
Key Considerations
Non-clinical testing
- Adhesive bond strength testing (5-20 MPa range)
- Ion release profile testing (if applicable)
- Film thickness testing for luting cements (max 25 µm)
- Net setting time testing (specific ranges based on application)
- Compressive strength testing for powder/liquid acid-base cements (≥50 MPa)
- Acid erosion testing for powder/liquid acid-base cements
- Working time testing for resin-modified cements (≥1.5 minutes)
- Flexural strength testing for resin-modified cements (≥10 MPa)
- Water sorption testing (≤40 μg/mm³)
- Water solubility testing (≤7.5 μg/mm³)
Biocompatibility
- Cytotoxicity
- Sensitization
- Oral Mucosa Irritation
- Acute Systemic Toxicity (Oral Application)
- Subacute/Subchronic Toxicity (Oral Application)
- Genotoxicity
Relevant Guidances
- Performance Testing and Safety Requirements for Single-Use Cutaneous Recording Electrodes
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
Related references and norms
- ISO 9917-1: Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements
- ISO 9917-2: Dentistry – Water-based cements Part 2: Resin-modified cements
- ISO 29022: Dentistry-Adhesion – Notched-edge shear bond strength test
- ISO 4049: Dentistry – Polymer-based restorative materials
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 7405: Dentistry –Evaluation of biocompatibility of medical devices used in dentistry
Original guidance
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