Post

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.

  1. Determine if your device falls within the scope of this guidance
  2. Conduct all required non-clinical testing according to specified methodologies
  3. Perform complete biocompatibility evaluation as per FDA guidance
  4. Prepare test reports and Declarations of Conformity (DoC) for all applicable tests
  5. Consider submitting a Pre-Submission if additional testing beyond guidance requirements is needed
  6. Compile all test results summaries and supporting documentation for 510(k) submission
  7. Ensure all performance criteria are met before submission
  8. Document any deviations with proper justification
  9. 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

  • 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

  • Technical Performance Testing for Dental Cements and Resin-Modified Materials
  • 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: 22224af934e2cbb0669fc57f764cd33d
This post is licensed under CC BY 4.0 by the author.