USFDA Med Dev Guidance: Animal Studies for Dental Bone Grafting Material Devices in 510(k) Submissions

On 22 August 2025, the U.S. Food and Drug Administration (FDA) released a comprehensive guidance document titled “Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions.” This guidance provides recommendations to sponsors on designing and conducting animal studies to support premarket submissions of dental bone grafting materials. The document reflects FDA’s ongoing commitment to ensuring that dental devices intended for bone regeneration and repair are safe, effective, and scientifically supported.

Bone grafting materials are regulated as Class II medical devices, often requiring 510(k) clearance before marketing in the United States. Given the biological complexity of bone healing, preclinical animal studies are essential to demonstrate biocompatibility, safety, and performance.

Dental bone grafting materials are widely used in procedures such as implant dentistry, periodontal regeneration, and maxillofacial reconstruction.

The FDA guidance emphasizes that animal studies often play a critical role in evaluating these devices, especially when human data are not yet available or sufficient. The purpose of the document is to:

• Provide clarity on FDA expectations for animal testing in 510(k) submissions.

• Ensure consistency across submissions, reducing delays due to incomplete study designs.

• Guide sponsors on selecting the right animal models, study endpoints, and reporting requirements.

This guidance applies to all dental bone grafting materials intended for use in:

• Periodontal defects

• Ridge augmentation

• Sinus lift procedures

• Peri-implant bone regeneration

It does not apply to materials outside dental use (e.g., orthopedic bone grafting). This guidance helps ensure that dental bone grafting devices entering the U.S. market are backed by high-quality preclinical data. Standardization benefits both manufacturers (clearer submission requirements) and regulators (streamlined review). Ultimately, it advances patient safety by ensuring that devices used in critical dental procedures perform as intended.

Key FDA Recommendations

A. Animal Studies

Animal Model Selection

• Use clinically relevant species that mimic human oral bone healing (e.g., dogs, sheep, or non-human primates).

• Consider anatomical similarity to human jaws, defect size, and bone remodeling characteristics.

Study Design Considerations

• Defect Type: Use critical-size or non-critical-size defects that reflect clinical scenarios.

• Control Groups: Include negative controls (empty defect) and positive controls (commercially available graft).

• Endpoints:

  • Histological assessment of new bone formation.

  • Radiographic or micro-CT evaluation for bone density and defect fill.

  • Mechanical testing to evaluate strength and integration.

• Study Duration: Must be long enough to assess both early healing and long-term integration (often ≥ 12 weeks).

• Sample Size: Should be statistically justified and sufficient for meaningful analysis.

B. Other Considerations

• Good Laboratory Practice (GLP): Conduct studies under GLP where possible.

• Ethical Standards: Use the 3Rs principle (Replacement, Reduction, Refinement) to minimize animal use.

• Study Reporting: Provide detailed methodology, raw data, statistical analyses, and justification for chosen models.

• Translation to Humans: Sponsors should discuss how animal results are expected to predict clinical outcomes in humans.

For full details, refer to the official FDA guidance documents:

• Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions (FDA Guidance Page)

• Download the Full Guidance (PDF)