FDA Guidance on Endosseous Dental Implants: Specific Aspects

Table of content

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to endosseous dental implants and endosseous dental implant abutments, describing the applicable performance criteria in the context of safety and performance based pathway. The document describes the applicable regulatory requirements, and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. 

At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.

Testing Performance Criteria

The FDA’s Safety and Performance Based Pathway provides a streamlined approach for evaluating endosseous dental implants and abutments by allowing manufacturers to demonstrate substantial equivalence through compliance with established performance criteria instead of direct predicate comparisons. The guidance outlines specific testing methodologies, performance benchmarks, and submission requirements necessary for ensuring the safety and efficacy of such devices.

According to the document, submitters should include a results summary for all tests and, when required, submit complete test protocols or reports. FDA may request additional data to validate performance compliance as necessary. 

For more information on submitting non-clinical bench testing, manufacturers are referred to FDA’s guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.

Testing Categories

The document further describes in detail specific testing categories, emphasizing the key aspects to be taken into consideration with respect to each of them.

1. Mechanical Bench Testing

Test Name: Dynamic Loading Test  

Methodology: Based on FDA-recognized ISO 14801 and Class II Special Controls Guidance for endosseous dental implants.  

For implants with non-standard diameters, criteria should align with the next highest diameter. For angled abutments, testing must include the largest intended angulation plus an additional 10°.

Test reports should include:

• Engineering drawings of the worst-case construct.
• Calculations of the moment arm.
• Testing setup details, including failure modes and lateral constraints elimination.

Devices with specific load limitations must include appropriate warnings in the labeling, e.g., recommendations against use in posterior or molar regions for implants with lower maximum loads.

2. Surface Cleanliness Analysis

Test Name: Surface Cleanliness Analysis for Blasted or Roughened Implants  

Methodology: Utilize scanning electron microscopy (SEM) and energy dispersive X-ray spectroscopy (EDS) to analyze the implant surface for particles and chemicals. Testing should cover multiple manufacturing lots, including sterilization and packaging stages.

Performance Criteria: No foreign particles or residual chemicals should be present on the implant surface.

Submission Requirements: Include magnified SEM/EDS images, detailed spectroscopy analysis, and a sample size justification demonstrating how analyzed locations represent the entire treated surface.

3. Sterilization and Reprocessing Validation

Test Name: Sterilization and Reprocessing Validation  

Methodology: Follow current FDA-recognized versions of sterilization and packaging standards, such as ISO 17665-1 (moist heat) or ISO 11137-1 (radiation sterilization). Validation must demonstrate sterility assurance levels (SAL) of 10⁻⁶ and provide information on the sterile barrier system’s maintenance of sterility.

Performance Criteria: The system must ensure device sterility and provide validated instructions for aseptic unpackaging.

Submission Requirements:

• Description of the sterilization process and sterile barrier system.
• Endotoxin-mediated pyrogenicity data for sterile devices.
• Instructions for end-user sterilization for non-sterile devices.

4. Biocompatibility Evaluation

Endpoints: The device must be evaluated for biocompatibility based on its classification as a permanently implanted device in contact with tissue/bone for over 30 days. Endpoints include:

• Cytotoxicity
• Sensitization
• Irritation
• Acute systemic toxicity
• Sub-acute and chronic toxicity
• Genotoxicity
• Material-mediated pyrogenicity
• Implantation and carcinogenicity risks

Rationale in Lieu of Testing: If the subject device uses identical materials and processes as a predicate device and has demonstrated a clean surface through SEM/EDS, additional biocompatibility testing may not be necessary. However, the authority explicitly states that the appropriate justification and documentation must be provided.

Performance Criteria: All tissue-contacting components must elicit an acceptable biological response.

Submission Requirements: Submit complete test reports unless a declaration of conformity suffices. Any adverse responses must be justified with supporting data or comparison to a legally marketed predicate.

Performance Considerations and Submission Information

According to the document, general considerations are: 

• Testing methodologies should follow FDA-recognized standards and include detailed reporting to confirm compliance.
• Where testing involves non-standard methods or deviations, submitters must provide robust justifications and alternative comparisons to predicate devices.

Furthermore, it is stated that when making a submission, product manufacturers should include the following components:

• Results summaries and, where applicable, complete test reports.
• Detailed descriptions of testing protocols and methodologies.
• Documentation of compliance with biocompatibility, sterilization, and performance benchmarks.

Regulatory Flexibility

Devices not fully compliant with the Safety and Performance Based Pathway may use traditional 510(k) programs requiring direct performance comparisons.

Conclusion

In summary, this guidance establishes clear and rigorous criteria for evaluating endosseous dental implants and abutments under the Safety and Performance Based Pathway. It is stated that medical device manufacturers can use the standards and approaches described in the document to streamline the regulatory process, ensuring their devices meet the highest benchmarks for safety and performance while expediting market entry.

Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/endosseous-dental-implants-and-endosseous-dental-implant-abutments-performance-criteria-safety-and

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