Combined with the past FDA clearances for obtaining access, cleaning and shaping, this clearance allows Biolase users to perform the complete root canal procedure using FDA cleared procedures.
Jake Philip, CEO of Biolase, said: “Clinically, we have developed and can now market a technology that is a better way to eliminate or avoid the infections that cause painful toothaches in millions of patients. Commercially, this clearance is a significant milestone for Biolase, in addition to strengthening our intellectual property; it provides our sales force, our North American distributor Henry Schein and international distributors around the globe with a powerful marketing advantage.”