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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).

  1. Determine if your device falls within the scope of this guidance
  2. Conduct all required non-clinical testing according to ISO 4823 based on material type
  3. Perform biocompatibility evaluation or provide documentation for identical materials
  4. Prepare test reports and Declarations of Conformity for all applicable tests
  5. Consider submitting a Pre-Submission if additional testing might be necessary
  6. Compile all test results and documentation for 510(k) submission
  7. Ensure all performance criteria are met before submission
  8. 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

  • 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

  • Dental Impression Materials: Performance Criteria and Testing Requirements
  • HTML / PDF
  • Issue date: 2024-09-30
  • Last changed date: 2024-09-27
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Dental, Premarket
  • ReguVirta summary file ID: 7b7a0994ecb5295739b305c8f663d341
This post is licensed under CC BY 4.0 by the author.