Background: Risk analysis file will never be closed in the technical documentation of the dental implants for the marketing purpose. In this paper the most common risk factors categorized as implant-related risks, surgeon-related risks, patient-related risks, and maintenance-related risks in the manufacturing process, application, the long term usage and the so-called survival rate of dental implants are studied.
Methods: The importance of any of the potential risk factors directly related to the product or the processes which are indirectly related to the product quality are assessed based on their severity and probability of occurrence. Proper measurement called as mitigations are considered to standardize the risks to the acceptable criteria.
Results: The equivalent risk assessment factors are compared in pre-mitigation and post-mitigation stages. The aim was to see whether the factor reduces to the acceptable or conditionally acceptable state for each risk or not.
Conclusion: Through this comprehensive study, the risk analysis file is completed however it can be even more complete, in the future, at this industry. In the further studies, discretizing the steps of severity or probability to finer steps, and ultimately converting them to a continuous form would be aimed.