Basically significant risk devices are to be use in supporting human life and present a potential risk to the patient’s health. The potential harm to subjects could be life-threatening, could result in permanent impairment of a body function or permanent damage to the body structure. for example dental implants which required clinical trials. In contrast, non significant risk devices are the ones that doesn’t represent any risk to the patient’s health for example dental laminates which are porcelain veneers to create perfect smiles.