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).
What You Need to Know? 👇
What is the Safety and Performance Based Pathway for dental impression materials?
It’s an optional FDA pathway allowing manufacturers to demonstrate substantial equivalence by meeting FDA-identified performance criteria rather than directly comparing to predicate devices. This approach can be less burdensome while maintaining safety standards.
Which dental impression materials are covered by this FDA guidance?
The guidance covers Class II dental impression materials (21 CFR 872.3660) including Types 0-3 elastomeric materials and Type B bite registration materials. It excludes optical impression systems, resin tray materials, and preformed trays.
What are the key performance tests required for dental impression materials?
Key tests include consistency (disc diameter), detail reproduction, linear dimensional change (≤1.5%), gypsum compatibility, elastic recovery (≥96.5%), and strain in compression. Specific criteria vary by material type (0-3 or B).
What biocompatibility testing is required for dental impression materials?
Manufacturers must evaluate cytotoxicity, sensitization, and oral mucosa irritation per ISO 10993-1. These materials are classified as surface devices with mucosal membrane contact for ≤24 hours duration.
Can manufacturers use existing biocompatibility data instead of new testing?
Yes, if the device uses identical raw materials and manufacturing processes as a predicate device with same tissue contact, existing documentation may establish substantially equivalent biocompatibility without additional testing.
When should manufacturers submit a Pre-Submission for dental impression materials?
Submit a Pre-Submission when additional testing beyond the guidance criteria may be necessary, or when determining eligibility for the Safety and Performance Based Pathway requires discussion with FDA before 510(k) submission.
What You Need to Do 👇
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
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
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