Laboratory Test Request

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

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Biomaterials,Bone Grafts,Dentistry and Dental Products,Healthcare and Medical,Medical Implants,

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