FDA Porcine Testing Synthetic Dental Bone Graft Material Comparison Study
Project Description
Contract Research Organization CRO needed to run a porcine model animal study to compare performance with our synthetic dental bone graft material against a predicate device. Protocol also needs to be written and shared. We also need a sham site to support our 510(k) application.
The porcine testing needs to be per the following FDA guidance documents:
- Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions (March 29, 2024).
- General Considerations for Animal Studies Intended to Evaluate Medical Devices (March 28, 2023).
Dental graft material is 1cc volumes, mixed with equal amount of sterile saline solution; B-TCP - 65% and Calcium Sulphate - 35%.
Project Information
Number:24-01118
Industry:Dentistry and Dental Products
