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Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments

This guidance covers root-form endosseous dental implants and endosseous dental implant abutments, which are Class II devices regulated under 21 CFR 872.3640 and 21 CFR 872.3630. The devices are intended for surgical placement in upper/lower jaw bones to support prosthetic devices and restore chewing function. The guidance specifically addresses devices made from titanium alloys conforming to ASTM F67, F136, or F1295 standards.

  1. Determine if device falls within scope of guidance based on materials and design characteristics
  2. Prepare detailed engineering drawings showing all required device characteristics
  3. Conduct dynamic loading testing if applicable (angled abutments)
  4. Perform surface cleanliness analysis for blasted/roughened implants
  5. Complete sterilization validation and packaging testing as applicable
  6. Conduct appropriate biocompatibility testing or prepare rationale for waiving tests
  7. Develop labeling with required warnings based on maximum endured load
  8. Prepare reverse engineering analysis if needed for compatibility claims
  9. Document test results in appropriate format with sample size justifications
  10. Consider Pre-Submission meeting if additional testing beyond guidance scope is needed

Key Considerations

Non-clinical testing

  • Dynamic Loading Test required for systems with angled abutments following ISO 14801
  • Maximum endured load requirements based on major thread diameter
  • Surface Cleanliness Analysis using SEM and EDS for blasted/roughened implants
  • No particles or residual chemicals should be present on the surface

Human Factors

  • Usability evaluation for aseptic presentation required for single-layered sterile barrier systems

Labelling

  • Specific warnings required based on maximum endured load values
  • Instructions for unpackaging process for single-layered sterile barrier systems
  • Validated sterilization cycle instructions for non-sterile devices

Biocompatibility

  • Assessment required for cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, sub-chronic toxicity, genotoxicity, implantation, chronic toxicity, and carcinogenicity
  • Testing can be reduced if using identical materials and processes as predicate device
  • Basic biocompatibility testing (cytotoxicity, sensitization, irritation) required even for standard materials

Safety

  • Sterilization validation to SAL 10-6 required for sterile devices
  • Sterile barrier system validation required
  • Endotoxin testing required for sterile devices

Other considerations

  • ISO 14801: Dentistry - Implants - Dynamic loading test for endosseous dental implants
  • ISO 17665-1: Sterilization of health care products – Moist heat
  • ISO 11135: Sterilization of health care products – Ethylene oxide
  • ISO 11137-1: Sterilization of health care products —Radiation
  • ISO 20857: Sterilization of health care products — Dry heat
  • ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
  • ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
  • ASTM F67: Standard Specification for Unalloyed Titanium
  • ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI
  • ASTM F1295: Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy

Original guidance

  • Testing and Labeling Requirements for Titanium Alloy Dental Implants and Abutments
  • HTML / PDF
  • Issue date: 2024-10-15
  • Last changed date: 2024-10-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Dental, Premarket
  • ReguVirta summary file ID: 331c660ed29a5aa13e81ae8d1b13cdb7
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