Post

Testing and Safety Requirements for Denture Base Resins

This guidance covers denture base resins (Class II devices, regulated under 21 CFR 872.3760) composed of materials such as methyl methacrylate, intended for fabrication of patient-specific denture bases for full or partial dentures. It includes five types of polymers/materials: heat-polymerizable, autopolymerizable, thermoplastic, light-activated, and microwave cured materials. The guidance excludes OTC relining/repairing resins, preformed denture teeth, and partially fabricated denture kits.

  1. Determine if device falls within scope of guidance
  2. Conduct all required mechanical testing according to ISO 20795-1
  3. Perform biocompatibility evaluation per ISO 10993-1
  4. For 3D printed resins, validate manufacturing process and document additional requirements
  5. Prepare Declaration of Conformity (DoC) for mechanical tests
  6. Submit complete test reports for biocompatibility unless DoC is appropriate
  7. Document all manufacturing processes and controls
  8. Prepare appropriate labeling including user instructions
  9. Consider Pre-Submission if additional testing beyond guidance is needed
  10. Prepare 510(k) submission following Safety and Performance Based Pathway requirements

Key Considerations

Non-clinical testing

  • Ultimate flexural strength testing according to ISO 20795-1
  • Flexural modulus testing according to ISO 20795-1
  • Stress intensity factor testing according to ISO 20795-1
  • Fracture work testing according to ISO 20795-1
  • Residual monomer testing according to ISO 20795-1
  • Water sorption testing according to ISO 20795-1
  • Water solubility testing according to ISO 20795-1

Labelling

  • Instructions for end-user if fabricated at point-of-care
  • Identification of compatible bonding agents
  • Instructions for relining or repair if applicable

Biocompatibility

  • Cytotoxicity testing
  • Sensitization testing
  • Irritation or Intracutaneous Reactivity testing

Safety

  • Compliance with ISO 20795-1 performance criteria for mechanical properties
  • Water sorption ≤ 32 μg/mm³
  • Water solubility requirements based on polymer type

Other considerations

For additively manufactured (3D printed) denture resins:

  • ISO 20795-1: Dentistry – Base polymers – Part 1: Denture base polymers
  • 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

  • Testing and Safety Requirements for Denture Base Resins
  • HTML / PDF
  • Issue date: 2022-04-13
  • Last changed date: 2022-04-12
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 82f706da5087f4703142bfbc2f8464a9
This post is licensed under CC BY 4.0 by the author.