On July 14, 2014, Intra-Lock International, Inc. filed a lawsuit against Joseph Choukroun, his company Process for PRF, SARL (France), and a series of U.S.-based distributors that sell Choukroun’s medical device kit for the production of platelet-rich fibrin (PRF). The lawsuit alleges that the Choukroun kit that is marketed as A-PRF is a Class II medical device that is not cleared for sale in the U.S. All Class II medical devices require premarket clearance from the Food and Drug Administration (FDA) before they can be sold in the U.S.
Intra-Lock International has received premarket clearance from FDA for its PRF production system known as the IntraSpinTM System. To date, the IntraSpinTM System is the only system for production of PRF cleared for sale by the FDA. It is important that all dentists using PRF in their practices use a system that has been evaluated and cleared by FDA, as the PRF system takes a patient’s blood, isolates the platelet-rich fibrin and then re-inserts the biological material into an open wound in a patient’s mouth. If that system does not have the types of design and quality controls, sanitation instructions or materials that FDA requires, a dentist could be endangering his patient’s wellbeing, report by Newsium.
Intra-Lock® initiated legal action to protect consumers from potentially unsafe PRF systems and dentists from the potential liability associated with using Class II devices that have not been cleared by the FDA. Intra-Lock® International’s FDA-cleared IntraSpinTM System is available not only in the U.S., but also in many European, Latin American and Asian countries.