Dental Impression Materials: Performance Criteria and Testing Requirements
This guidance covers dental impression materials intended for providing models for study and production of restorative prosthetic devices. It specifically applies to Class II devices regulated under 21 CFR 872.3660 (product code ELW), including different types of materials (Type 0-3 for various consistencies and Type B for bite registration).
Recommended Actions
- Determine if your device falls within the scope of this guidance
- Conduct all required non-clinical testing according to ISO 4823 based on material type
- Perform biocompatibility evaluation or provide documentation for identical materials
- Prepare test reports and Declarations of Conformity for all applicable tests
- Consider submitting a Pre-Submission if additional testing might be necessary
- Compile all test results and documentation for 510(k) submission
- Ensure all performance criteria are met before submission
- Maintain complete test documentation for potential FDA review
Key Considerations
Non-clinical testing
- Consistency (test disc diameter) according to material type
- Detail reproduction (line width reproduced)
- Linear dimensional change (≤1.5%)
- Compatibility with gypsum
- Elastic recovery (≥96.5%)
- Strain in compression
- For Type B materials: compression set and hardness requirements
Biocompatibility
- Required testing for surface devices with mucosal membrane contact (≤24 hours):
- Cytotoxicity
- Sensitization
- Oral Mucosa Irritation
- Alternative: Documentation of identical materials and manufacturing to predicate device
Other considerations
- Device must be for prescription use only
- Testing information should include results summary, test protocols, and complete test reports
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Safety and Performance Based Pathway for 510k Substantial Equivalence Demonstration
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
Related references and norms
- ISO 4823: Dentistry - Elastomeric impression and bite registration 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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