Intra-Lock Files Suit to Protect Consumers from Unapproved Dental Device
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--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.
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.
Intra-Lock® International Inc., headquartered in Boca Raton, Florida, USA, is a leading provider of innovative dental restoration solutions including a wide range of dental implants, bio-materials and prosthetic abutments. Intra-Lock dental implants are biologically driven in design. Their architectures are “site-specific,” which encourages physiologic harmony and ensures an ideal tissue response when compromised bone volume, density and/or extraction site defects are encountered. Intra-Lock’s advanced bioactive surface, OSSEAN®, its ergonomic delivery technology, Drive-Lock™ and its exceptional abutment stability offer a complete solution for dental implant specialists. In addition, Intra-lock’s FDA cleared Intra-Spin™ System is designed to enable an efficient, cost effective and simple chairside protocol for the fabrication of one of the most exciting tools in regenerative medicine, L-PRF (Leukocyte- and Platelet- Rich Fibrin). For more information, please visit our informative website www.intra-lock.com.